Endo Pharmaceuticals / Par Pharmaceutical

59 job(s) at Endo Pharmaceuticals / Par Pharmaceutical

Endo Pharmaceuticals / Par Pharmaceutical Horsham, PA
Description Job Summary - a concise overview of the jobThe Associate Director, Production Planning has leadership, coordination and delegation responsibility for the planning of drug product and drug substance manufacturing and packaging activities. The role supports and assists the detail scheduling and capacity constraints for manufacturing and packaging, optimizing methods and processes related to scheduling production activity. The Associate Director will manage planner/buyers for both packaging components and raw materials to support monthly Production plans. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc. Horsham ,PA,  Rye, NY, Cranbury, NJ Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeMaster Production Schedule§  Normalize and manage the production scheduling process to ensure market demand is met.§  Communicates market inventory, sales and forecast information to all interested parties.§  Communication and coordination of the Master plan from EVL.§  Set detail weekly and long-term production schedules with Par Manufacturing and Packaging departments.§  Ownership of Capacity planning as it pertains to review capacity constraints against the Manufacturing and Packaging schedules to assure monthly plans can be achieved.40%Scheduling Tools§  Manages the use of relevant scheduling tools.§  Ensures accuracy of net requirements calculations.§  Coordinates the use of multiple toolsets (ERP, Inventory Status Reporting, manufacturing/packaging center feedback, etc.).20%Customer Support§  Manages customer support interactions.§  Negotiates with customers and manufacturing, explaining constraints to each and ensuring the best possible result to any demand or supply situation.§  Support EVL Master planning directives.20%Inventory Management §  Acts as a key contributor to monthly Sales Operations and planning meetings.§  Provides insight input on inventory levels and supply issues.20%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  B.S. degree required.§  10+ years’ experience within the pharmaceutical industry with a concentration in business development and supply chain. KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Strong working knowledge and skills with ERP systems (SAP preferred).§  Experience with MS Excel, MS Word, MS Project.§  Knowledge of MPS, MRP,  and Shop Floor ControlSkills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Ability to develop a strategic plan and execute it.§  Effective communication skills to work professionally with internal and external personnel at all levels.§  Ability to work independently and manage multiple complex projects and effectively utilize, supervise and train staff.§  Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.§  Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities.§  Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.§  Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.§  Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.§  Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals.§  Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.§  Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.§  Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.§  Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.§  Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Incumbents are subject to extended periods of sitting, standing and walking.§  Use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl.§  Talk or hear; and taste or smell, looking at monitor.§  Moderate noise levels and some business travel.
Endo Pharmaceuticals / Par Pharmaceutical Horsham, PA
Description Job Summary - a concise overview of the jobThe QC Analyst I - Chemistry will provide bioanalytical expertise for the Quality Control department.  Key areas of focus are development and implementation of the quality aspects of late stage or marketed product strategy.  This role is also responsible for maintaining sample traceability via QC logbooks.All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.QC Chemistry Department. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeQC Testing/Safety§  Testing responsibilities may include RP-HPLC, SEC, KF, FT-IR, SDS-PAGE, and UV-Vis.§  Adheres to Company safety procedures and guidelines on a daily basis.60%Sampling / Documentation§  Maintains sample traceability via QC logbooks.15%GMP Compliance§  Applies knowledge of Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) on a daily basis.10%Technical Writing & Investigations§  Assists with preparing new SOPs / test methods or revising of existing documentation.§  Under supervision, writes Change Controls, Deviation Investigations (DI’s), Laboratory Assessments (LA’s), CAPA’s, and OOS investigation.10%Other Tasks§  Other duties as assigned by QC management.5%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  B.S. in a Biological Science or related field with a minimum of 0-3 years’ experience in pharmaceutical or biotechnology industry required.§  General experience in a development, quality, or manufacturing environment preferred. KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Functional and technical knowledge in protein chemistry and standard analytical techniques used in the biopharmaceutical industry (e.g., HPLC, FT-IR, SDS-PAGE, UV-Vis, IEF, Capillary Electrophoresis, ELISA).§  General knowledge of cGMP practices, ICH requirements, stability, and validation required.§  Understanding of basic statistical analysis and familiarity with the use of databases is desirable. Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Strong verbal and communication skills required.§  Proficient in common software applications.§  Ability to handle multiple priorities in a fast paced environment.§  Demonstrates excellent interpersonal skills and flexibility.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Lifting up to 40 lbs.§  Able to stand for extended periods of time.
Endo Pharmaceuticals / Par Pharmaceutical Malvern, PA
Description Job Summary - a concise overview of the jobThe Process Engineer will be responsible for supporting process engineering initiatives as they pertain to the CCH BDS manufacturing process, manufacturing facility, and utility areas.  This includes new equipment and/or system installations, and equipment, systems, and process improvement initiatives.  Responsible for trouble-shooting, change management, deviations/CAPAs, technical documentation in support of CCH BDS manufacturing operations.  Responsible for supporting the Horsham site Statistical Process Control (SPC) Program.All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Process Engineering and validation, supporting CCH BDS manufacturing operations at the Horsham site.  Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeProcess Engineering / Manufacturing Operations§  Support process engineering activities associated with the Endo Horsham site and the manufacture of CCH BDS, including manufacturing equipment upgrades, addition of new equipment, and capital engineering projects.  Author change management documentation for manufacturing equipment, process, and utilities.30%§  Assist in troubleshooting manufacturing equipment and assist in completing process deviation investigations/unplanned events.  Author, review, and approve cGMP documentation - manufacturing process and equipment deviation investigations, CAPAs, and technical documentation.25%§  Support CCH process scale-up, development activities, and technology transfer projects.15%§  Support the Horsham Site Statistical Process Control and Continued Process Verification programs.  Utilize statistical control software to analyze and trend process and facility data and results.15%§  Support the Horsham site validation program - Author/review/approve manufacturing equipment and process validation plans, risk assessments, validation status assessments, protocols, and reports.§  Perform hands-on validation testing including compiling qualification documentation, performing temperature mapping, collecting samples, and other field activities.10%§  Cross-train with the manufacturing department on cGMP operations including upstream, downstream, and support operations5%Total100%  QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Bachelor’s degree in Chemical, Biochemical, or Biological Engineering or equivalence in related experience§  Minimum 3 years’ experience working in a cGMP biopharmaceutical manufacturing environment, Process Engineering, Equipment and Process Validation and Maintenance, and/or Manufacturing Technology/Technology Transfer§  Solid background in fermentation and process scale-up of microbial proteins and enzyme production KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Thorough technical knowledge of automated or semi-automated fermenters, sterilization techniques/SIP, autoclaves, and aseptic techniques.§  Knowledge of GMP critical systems like HVAC, WFI, Clean steam, and CIP.  §  Firm understanding of industry standard practices for biopharmaceutical production with respect to GMP systems and documentation.§  Good understanding and experience in systems and equipment validation, writing, executing, and reviewing validation protocols§  Experience with statistical control software (SAS-JMP, SPSS, R, MATLAB, Minitab) is a plusSkills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Solid technical writing skills.§  Clear communicator, both verbally and written, to subordinates and peers.§  Customer-service focused individual with the ability to “roll-up sleeves”§  Works well with others and establishes working relationships with Manufacturing, Quality, Facilities and Engineering, and Manufacturing Technology/Biotechnology Operations§  Ability to troubleshoot process and equipment issues.  Innovative and efficient when solving problems, considers possible implications of the decisions made.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  This position may require working with or around hazardous substances, and may be subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees§  Travel (10%), Lifting, Physical Constraints
Endo Pharmaceuticals / Par Pharmaceutical Horsham, PA
Description Job Summary - a concise overview of the jobThe Warehouse Operations Associate is responsible for the storage and inventory management of GMP drug products and substances including the dispensing operations for raw materials (under environmentally controlled conditions) and consumables. This role is also responsible for the distribution/shipping of temperature-controlled GMP materials. Additional responsibilities include but are not limited to the procurement process, warehousing, quality control, salvage and scrap disposal,, and control of inventory.All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Warehousing Operations Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeWarehouse Operations & Inventory Control§  Manages the storage of GMP drug substances and drug products under appropriate environmental conditions.§  Monitors/manages inventory movements in SAP or equivalent inventory system.§  Manages inventory in SAP (or equivalent inventory system) of GMP raw materials and consumables. §  Coordinates labeling and proper storage of materials.§  Acquires documentation as necessary (i.e., Certificates of Analysis/Compliance, etc.) from vendors per material release requirements.§  Conducts dispensing operations including but not limited to extracting picklists/labels for dispensing from SAP, and dispensing consumables.§  Assists with QC sampling of raw materials.§  Monitors warehouse freezers/refrigerators and general storage of materials. §  Maintains dock integrity.§  Orders and maintain warehouse supplies.45%Shipping & Receiving§  Receives deliveries of GMP/non-GMP materials. §  Assures transport of non-GMP materials to appropriate personnel. 45%§  Performs shipping/distribution of ambient and temperature controlled GMP and clinical materials. §  Trains/supervises staff which assist in the operation.  This includes arranging carriers, creating/obtaining shipment documentation, packing out shipments (in accordance with approved procedures where available), and ensuring that shipments are picked up by the carrier.§  Oversees documentation of the shipments including download of temperature monitoring information collected during the shipmentDocumentation§  Authors and revises warehouse documentation as necessary.5%Investigation§  Assists in the resolution of warehouse deviations/non-conformances.§  Assists with troubleshooting processes and equipment.2.5%Compliance§  Ensures warehouse operations are in compliance with approved SOPs and controlled documentation.§  Ensures all applicable regulations, guidelines, safety policies and procedures are followed.§  Assists in warehouse tours provided to regulatory authorities.2.5%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  High School diploma and/or related work experience.§  2-5 years’ experience in a GMP pharmaceutical or biotechnology setting.§  Experience in warehouse operations and/or GMP operations preferred.§  ERP experience preferred. KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Working knowledge of cGMP practices for biopharmaceutical products.§  Working knowledge of temperature controlled shipping and logistics.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Ability to work well with others and establish working relationships with Warehouse personnel as well as Quality, Facilities/Engineering/Validation, and Manufacturing.§  Ability to perform dispensing activities as described above with minimal supervision.§  Exhibits attention to detail, accuracy in work, and integrity of character.§  Self-starter, shows willingness to learn and problem-solve.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Standing for long periods of time.§  Ability to wear a sterile gown and don shoe covers on a periodic basis.§  Ability to lift 40 pounds.
Endo Pharmaceuticals / Par Pharmaceutical Horsham, PA
Description Job Summary - a concise overview of the jobThe Supervisor, Downstream Processing supervises purification and production support activities for the development, validation, and cGMP manufacture of collagenase clostridium histolyticum bulk drug substance (CCH BDS). This hands-on supervisory position requires coordinating weekly and daily production schedules and shift-work within manufacturing to meet overall department and company timelines. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Responsible for the purification and production support activities for the Horsham, PA site. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeManufacturing / API Supply§  Supervises purification processes for commercial and clinical API production.§  Supervises team in hands-on capacity during cGMP operations and assists with daily production scheduling activities.§  Provides timely technical input to support on-going operations and resolve manufacturing deviations/non-conformances.§  Troubleshoots processes and equipment within the GMP facility as required and performs documentation closeout activities to release processes and equipment for production as required.§  Supervises purification process scale-up or development activities as needed.§  Authors, revises, and reviews manufacturing, equipment, facility and utility documentation, including but not limited to: SOPs, forms, master batch records, protocols, and reports.75%Validation & Continuous Improvement§  Works with Validation and leads process, equipment, and cleaning validation initiatives within the GMP facility.§  Leads equipment & system validation and cleaning efforts and authors/implements change controls associated with purification and support equipment, processes, and utilities.§  Identifies and supports continuous improvement initiatives.10%Training§  Trains, coaches, and mentors Process Engineers and Manufacturing Associates; participates in cross-training initiatives, as appropriate.§  Oversees and adjusts training programs within the team, ensuring that direct reports are current on training requirements.10%Compliance§  Ensures manufacturing operations are established and maintained in compliance with all applicable regulations, guidelines and safety policies and procedures.§  Assists QA, as required, with internal and external audits.5%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Bachelor’s degree in Biological Sciences or Bioengineering, or related field; Master’s Degree, a plus.§  Minimum 6+ years working in a biopharmaceutical cGMP manufacturing environment, technology development, technology transfer and validation.§  Experience supervising, coaching, and/or mentoring junior level associates.§  Strong background in protein purification and process scale-up.§  Experience working with or in commercial and/or clinical manufacturing groups.KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Knowledge of automated or semi-automated chromatography and filtration systems required.§  Working knowledge of cGMP and equipment, cleaning, and process validation practices for biopharmaceutical products.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Works well with others and establishes working relationships with Quality, Facilities/Engineering/Validation, Process Validation/Development, and Manufacturing.§  Exhibits attention to detail, accuracy in work, and integrity of character.§  Exhibits an open and constructive communication style based on the need of the receiver and by using the appropriate communication method.§  Innovative and efficient when solving problems, considers possible implications of the decisions made.§  Demonstrated ability to plan daily activities for self and team and resolve problems in area of expertise.§  Ability to lead and develop a team in order to accomplish individual and corporate goals.§  Promotes a culture of quality and safety in the manufacturing facility.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Ability to stand for long periods of time.§  Ability to wear a sterile gown and don shoe covers on a daily basis.§  Ability to lift 40 pounds.
Endo Pharmaceuticals / Par Pharmaceutical Horsham, PA
Description Job Summary - a concise overview of the jobThe successful candidate will execute and oversee the execution of Collagenase Clostridium Histolytium in-process and release test methods for the Bioprocess Technical Operations group.  Additionally, the scientist wiloptimize & troubleshoot existing assays, develop new assays, perform analytical assays in support of process &  product development, and lead or conduct analytical method transfer & validation. In addition, the candidate will act as a subject matter expert for analytical technologies at the Horsham site. All of the above responsibilities require independent execution with general guidance from BTO management.All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.This role will work cross functionally with Bioprocess Technical Operations scientists, Quality Control, Manufacturing, R&D, Quality Assurance, Regulatory Affairs, and other organizations across the company to execute assigned objectives.  The position may also have supervisory responsibility in either a short duration capacity or longer duration as needed. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeProcess Development·        Support bioprocess technical operations studies, process development, and validation by developing and performing various assays for process samples.40%Assay Development & Optimization·        Develop & optimize enzymatic assays, immunoassays, electrophoresis, chromatography (CE, RP-HPLC, SE-HPLC, etc.), and other methods.·        Author protocols, reports, SOPs/test methods as needed to support the development and optimization of assays.·        Provide training to QC and other relevant personnel during assay development/optimization and transfer.·        Coach and provide technical guidance to junior scientists in method development and validation as well as troubleshooting of method. 50%CMC / R&D§  Author and review CMC documents and correspondence.§  Partner with R&D colleagues to design and execute studies in support of clinical and pre-clinical development.50%People Management§  Manange subordinate staff, including weekly workload assignments and projet/study management of the assigned work. §  Mentor junior staff, both direct report(s) and team members40%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  BS degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Cell Biology, or related discipline + min. 12  years’ direct experience;§  MS degree in the above disciplines + min. 12 years’ relevant experience OR§  PhD in the above disciplines + min. 10 years’ relevant experience is preferred.§  Extensive hands-on experience in electrophoresis, chromatography, enzymatic assays and immunoassays for therapeutic proteins. §  Experience working with or supporting late stage clinical and commercial products preferred§  Previous people management preferred. KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Extensive knowledge of the biologic process and analytical development life cycle, cGMP, cGLP and FDA/ICH guidelines.§  Subject matter expert for analytical technologies.§  Extensive knowledge of analytical chemistry and concepts in developing and validating methods to meet correct pharmaceutical standards.§  Strong knowledge of ANDA product development process.§  Extensive knowledge of FDA, ICH and USP guidance and regulations.§  Superior knowledge of major analytical techniques such as HPLC/UPLC, GC, and FTIR etc.§  Additional expertise in analytical techniques such as residual DNA and residual host cell protein analyses would be beneficial.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Design and execution of analytical testing in an independent manner with minimal guidance from BTO management§  Strong method development skills, including optimization, qualification/validation, troubleshooting, and implementation of assays.§  Ability to exhibit open and constructive communication style based on the need of the receiver(s) and by using the appropriate communication method.§  Strong data and statistical analysis skills required; experience using statistical analysis software preferred.§  Able to plan & execute complex technical activities and projects in a dynamic, team based environment with the ability to work independently when needed; troubleshoot and develop/validate assays with little to no supervision.§  Strong organizational and time management skills.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Standing for moderate periods of time.§  Wearing lab coat, gloves, and other personal protective equipment required for working in the laboratory/biologic cleanroom environment as required, to carry out assigned responsibilities.§  Travel as needed to other internal company sites, third party & partner sites, but not expected to exceed 5-10% of time on an annual basis.
Endo Pharmaceuticals / Par Pharmaceutical Malvern, PA
Description Job Summary - a concise overview of the job Responsible for playing a leadership role in the execution of Endo’s portfolio enhancement and expansion strategy through the identification, evaluation, and advancement of new business opportunities that contribute to sustainable business growth.  Specifically, this role will be responsible for working closely with our Marketing, R&D, Tech Ops, and Market Analytics and other functions to evaluate strategic fit and value potential of external opportunities for our Medical Therapeutics, Medical Aesthetic, Sterile Injectable, Generic business units.  In addition, the role will serve as PM&SM representative on the Xiaflex Life Cycle Management (LCM), early product planning cross-functional team.  The role will also be responsible for leading efforts, in collaboration with R&D and Strategic Sourcing, to identify drug delivery platform technologies that can be licensed and/or acquired that will serve as a source of new product generation to expand Endo’s portfolio.  In addition, this individual will lead a cross-functional team to building a comprehensive road-map and play-book for pre-launch planning of complex generics and 505b2 brands (including those sold through specialty pharmacy / limited distribution) to enhance probably of commercial success. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Estimated 70% Portfolio Management/Expansion and 30% Lifecycle Management of in-line Brands Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeNew Product Identification, Evaluation & SelectionPlay a pivotal role in the execution of the portfolio expansion strategy via identification and evaluation of new product opportunities in both Medical Therapeutics and Medical Aesthetics Contribute to ongoing identification and evaluation of new product ideas that are aligned with established portfolio expansion strategiesLead, in collaboration with PM&SM Head, the evaluation and selection of complex-generics as one path for Sterile Injectables and Retail Generic  growth and higher margins−     Build robust go-to-market process to ensure greater commercial success SI and Gx Channel StrategyLead, in collaboration with Market Access, development of a Specialty Pharmacy channel strategy as a path for Sterile Injectables and Retail Generic business unit growthEvaluation of Drug Delivery PlatformsServe as Commercial lead for exploring drug delivery platforms to facilitate growth across the BUs (implications for LCM of existing brands and new products development with IP and/or regulatory exclusivity)New Product PlanningServe as PM&SM representative on early product planning cross-functional teams for Xiaflex & QwoTotal100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  PharmD or advance science degree in pharmaceutical related sciences§  BS in Business, MBA preferred§  Minimum 15 years’ experience in marketing, new product planning, product development, and portfolio strategy.§  Prior business development experience a plus§  U.S. based commercial marketing, strategic marketing, portfolio/franchise management,  and strategic planning experience§  Proven experience in being able to build strategy and supporting tactics and related execution processes§  Strong track record of successfully working cross-functionally with R&D, Tech Ops, Commercial, Finance, Business Development, Legal, Supply Chain and other functions.§  Experience working with field based sales force and managed care issues to address product launch challenges§  Experience with identifying and understanding implications of scientific and commercial market trends and their relevance in assessing product portfolio and commercial opportunities§  Project management experience§  Experience developing concise and audience-focused communications, both written and for presentationKnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Strong understanding of marketing business processes and pharmaceutical regulatory requirements§  Analytics marketing tools and integrated marketing techniques§  Strong specialty branded pharmaceutical knowledge, and hospital experience§  Previous experience with successful partnerships with both Research & Development, Commercial Operations, Regulatory and ComplianceSkills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Strong influencing skills with those over whom there is no immediate supervisory capacity to achieve objectives§  Results oriented, attention to accuracy and detail, able to set priorities, and willing to take appropriate risks§  Ability to interface with key customers, KOLs, physicians, pharmacists, industry contacts, and consultants to accomplish corporate objectives§  Skill to perform complex analyses of data and documents and understand marketing and scientific terminology§  Proven track record of developing and implementing strategic business plans that deliver clear measurable outcomes §  Strong project management skills, ability to manage multiple high priorities, identify resource needs, drive to completion, prepare reports, evaluate results and make go/no-go decisions§  Strong budget management skills§  Excellent interpersonal, and oral and written communication skills.  Skilled in presenting and tailoring presentation to audience, engaging audience and adapting to last minute changes§  Skilled in Microsoft Office applications (Word, PowerPoint, Excel).§  A proven track record of being able to integrate own thinking into the work of other teams§  Ability to lead teams and support change§  Ability to represent company in a leadership capacity at a variety of external forums.§  Customer centric – ability and appreciation to clearly understand the unique needs of the customer; ability to translate understanding into effective development and delivery of relevant solutionsPhysical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Ability to travel (estimated travel: 10- 20% domestic and international) Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.
Endo Pharmaceuticals / Par Pharmaceutical Horsham, PA
Description Job Summary - a concise overview of the jobThe primary focus of the Manufacturing Specialist, Downstream Processing is to author investigations associated with production events, supports related CAPA(s), and initiates change requests as required.  On a secondary basis, this individual will work in a hands-on capacity in the cGMP purification and production support areas to manufacture collagenase clostridium histolyticum bulk drug substance (CCH BDS). This role is expected to have a strong level of technical expertise in the purification area. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Works closely within the Manufacturing department at the Horsham, PA site and collaborates with Manufacturing Technology, Quality Control, Quality Assurance, Validation, Regulatory Affairs, Warehouse Operations, and Planning & Materials Management as necessary to handle production events, CAPAs, and change requests. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeTechnical Documentation,Investigation, and Continuous Improvement§  Authors, revises and reviews manufacturing and process equipment documentation.§  Authors investigation documentation and participates in/resolves manufacturing events/non-conformances.§  Creates and/or completes CAPA(s) resulting from manufacturing events.§  Author and implement change requests to support changes to processing, batch records, and equipment.§  Identify and support continuous improvement initiatives.  Engages with supervisors and managers to optimize the manufacturing process.§  Facilitate the upkeep of purification owned equipment.  Resolve equipment issues with engineering/facilities and contact vendors as needed.65%Manufacturing & Compliance§  Performs and supports purification process scale-up, cGMP manufacture and validation activities.§  Performs and supports manufacturing production activities to operate chromatography systems, ÄKTA chromatography controllers, UF/DF skids, perform sterile filtrations, prepare production buffers, and clean equipment.§  Supports validation efforts associated with purification equipment and processes.§  Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.30%Training§  Acts as qualified trainer for SOPs and procedures in functional area.§  Trains Manufacturing Associates of all levels as appropriate.§  Participates in cross-training initiatives as appropriate.5% 100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  High school diploma is required with a minimum of 5-7 years’ working in a pharmaceutical/biopharmaceutical cGMP manufacturing environment, technology development, technology transfer, validation, OR§  AS degree with a minimum of 4 years’ relevant experience noted above OR§  BS degree in Biological Sciences or Bioengineering with a minimum of 2 years’ relevant experience.§  Experience working with or in commercial and/or clinical manufacturing groups.§  Experience with CIP, chromatography systems, TFF skids, aseptic operations, integrity testers.§  Experience with authoring cGMP documentation (SOP, BR, forms) as well as authoring/executing investigations, CAPA, change controls, validation/technical protocols.§  Strong background in purification and process scale-up of proteins and enzymes is required. KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Working knowledge of cGMP practices, guidelines, validation, and equipment cleaning practices for biopharmaceutical products.§  Working knowledge of chromatographic and UF/DF principles.§  General knowledge of quality systems, e.g. unplanned event investigation, CAPA, change control.§  Demonstrated ability to resolve equipment and process problems in area of expertise.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Demonstrated ability to write clearly and succinctly for the technical community and can construct logical arguments well.§  Demonstrated ability to resolve equipment and process problems and to plan daily activities for self and resolve problems in area of expertise.§  Works well with others and establishes working relationships with Quality Assurance, Quality Control, Facilities/Engineering, Manufacturing Technologies, Validation, and Manufacturing.§  Exhibits attention to detail and accuracy in work, and integrity of character.§  Self-starter, shows willingness to learn and problem-solve.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Ability to stand for long periods of time.§  Ability to wear a sterile gown and don shoe covers on a daily basis.§  Ability to lift 40 pounds.
Endo Pharmaceuticals / Par Pharmaceutical Horsham, PA
Description Job Summary - a concise overview of the jobThe Manufacturing Associate II, Upstream Processing works in a hands-on capacity in the cGMP fermentation and production support areas to manufacture collagenase clostridium histolyticum bulk drug substance (CCH BDS). This role authors and revises manufacturing and process equipment documentation and is responsible for supporting necessary fermentation and production activities, including validation and development work as needed.  All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Fermentation and related manufacturing operations for the Horsham, PA site. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeManufacturing & Compliance§  Performs daily fermentation steps of cGMP manufacture of CCH BDS.§  Works in a hands-on capacity to operate fermenters, perform seed scale-up, sterilize equipment, prepare media solutions, and clean equipment as required.§  Ensures work is completed in compliance with approved SOPs, batch records, and controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followed.80%§  Assists with process, equipment, and cleaning validation initiatives.10%Documentation§  Authors and revises manufacturing and process equipment documentation.5%Investigation§  Assists in the resolution of manufacturing deviations/non-conformances.§  Under general supervision, assists with troubleshooting processes and equipment.5%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  High school diploma is required with a minimum of 3-5 years working in a pharmaceutical/biopharmaceutical cGMP manufacturing environment, OR§  AS degree with 2-4 years’ relevant experience noted above OR§  BS degree with 1-3 years’ relevant experience noted above.§  Experience working with fermenters, holding tanks, aseptic operations, seed scale-up, CIP and SIP of process equipment. KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Working knowledge of cGMP practices, ICH guidelines, and validation practices.§  Working knowledge of fermenters, holding tanks, aseptic operations, seed scale-up, and cleaning and sterilization procedures for biopharmaceutical products.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Demonstrated ability to troubleshoot and resolve equipment and processing issues.§  Works well with others and establishes working relationships with Quality, Facilities/Engineering/Validation, Process Validation/Development, and Manufacturing.§  Exhibits attention to detail, accuracy in work, and integrity of character.§  Self-starter, shows willingness to learn and problem-solve.§  Has technical aptitude to learn and operate production equipment.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Ability to stand for long periods of time.§  Ability to wear a sterile gown and don shoe covers on a daily basis.§  Ability to lift 40 pounds.
Endo Pharmaceuticals / Par Pharmaceutical Horsham, PA
Description Job Summary - a concise overview of the jobThe Manufacturing Associate II, Manufacturing Support Services works in a hands-on capacity in the cGMP production support areas (buffer preparation, equipment cleaning, etc.) to support manufacture of collagenase clostridium histolyticum bulk drug substance (CCH BDS). This role is responsible for the inventory, preparation, and storage of equipment and supplies related to cGMP production and authors and revises SOPs and forms applicable to manufacturing and process equipment documentation.This role supports necessary production and production-related activities, including validation and development work as needed and assists in training new hires and junior team members on production support activities and procedures.  All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Production and related manufacturing operations for the Horsham, PA site. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeManufacturing & Compliance§  Performs daily weigh/dispense, buffer preparation, and other process support operations for cGMP manufacture of CCH BDS.§  Ensures work is completed in compliance with approved SOPs, batch records, and controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followed.§  Enters/updates data into compliance documents and computer applications.§  Responsible for the inventory, preparation, and storage of equipment and supplies related to cGMP production.§  Assembles, cleans, and sterilizes production equipment using glassware washers, autoclaves, and CIP technologies.§  Assists with and executes process, equipment, and cleaning validation protocols.85%Investigation§  Assists in the resolution of manufacturing deviations/non-conformances.§  Under general supervision, assists with troubleshooting processes and equipment.5%Documentation§  Authors and revises SOPs and forms applicable to manufacturing and process equipment documentation. §  Documents work as per SOPs in logbooks, forms, and batch records.5%Training§  Assists in training new hires and junior team members on production support activities and procedures.5%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  High school diploma is required with a minimum of 3- 5 years working in a pharmaceutical/biopharmaceutical cGMP commercial or late-stage clinical manufacturing environment, OR§  AS degree with 2-4 years’ relevant experience noted above OR§  BS degree with 1-3 years’ relevant experience noted above.§  Experience with CIP, glassware washers, autoclaves, buffer/media preparation, filtration, integrity testers, and aseptic operations. KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Working knowledge of cGMP practices, ICH guidelines, and validation practices.§  Working knowledge of cGMP and equipment cleaning and sterilization practices for biopharmaceutical products.§  General understanding of chromatographic and UF/DF principles.§  Has familiarity with the use of databases.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Follows schedules and work plans, and coordinates with the Manufacturing group to provide timely support functions.§  Works well with others and establishes working relationships with Quality, Facilities/Engineering/Validation, Process Validation/Development, and Manufacturing.§  Exhibits attention to detail, accuracy in work, and a strong sense of integrity.§  Self-starter, shows willingness to learn and problem-solve.§  Has technical aptitude to learn and operate production equipment.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Ability to stand for long periods of time.§  Ability to wear a sterile gown and shoe covers on a daily basis.§  Ability to lift 40 pounds.
Endo Pharmaceuticals / Par Pharmaceutical Horsham, PA
Description Job Summary - a concise overview of the jobThe Manufacturing Associate I, Upstream Processing works in a hands-on capacity in the cGMP fermentation and production support areas to manufacture Collagenase Clostridium Histolyticum (CCH) bulk drug substance (BDS).  This role is responsible for supporting necessary fermentation and production activities, including validation and development work as needed. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Fermentation and related manufacturing operations. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeManufacturing and Compliance§  Performs daily fermentation steps of cGMP manufacture of CCH BDS:o   Work in hands-on capacity to operate fermenters, perform seed scale-up, sterilize equipment, prepare media solutions, and clean equipment as required.o   Ensures all work is completed in compliance with approved SOPs, batch records, controlled documentation, and that all applicable regulations, guidelines, safety policies and procedures are followed.90%§  Assists with process, equipment, and cleaning validation initiatives.5%Investigation§  Assists in the resolution of manufacturing deviations/non-conformances.§  Assists with troubleshooting processes and equipment.5%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  High School Diploma is required with a minimum of 0-3 years working in pharmaceutical/biopharmaceutical cGMP manufacturing environment.KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  General knowledge of cGMP, ICH guidelines, and general validation processes.§  General knowledge of cleaning and sterilization procedures for biopharmaceutical products.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Works well with others and establishes working relationships across functional departments - Quality, Facilities/Engineering/Validation, Process Validation/Development, and Manufacturing.§  Exhibits attention to detail, accuracy in work, and integrity of character.§  Self-starter, shows willingness to learn and problem-solve.§  Has technical aptitude to learn and operate production equipment.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Ability to stand for long periods of time.§  Ability to wear a sterile gown and don shoe covers on a daily basis.§  Ability to lift 40 pounds.
Endo Pharmaceuticals / Par Pharmaceutical Horsham, PA
Description Job Summary - a concise overview of the jobThe Manufacturing Associate I, Upstream Processing works in a hands-on capacity in the cGMP fermentation and production support areas to manufacture Collagenase Clostridium Histolyticum (CCH) bulk drug substance (BDS).  This role is responsible for supporting necessary fermentation and production activities, including validation and development work as needed. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Fermentation and related manufacturing operations. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeManufacturing and Compliance§  Performs daily fermentation steps of cGMP manufacture of CCH BDS:o   Work in hands-on capacity to operate fermenters, perform seed scale-up, sterilize equipment, prepare media solutions, and clean equipment as required.o   Ensures all work is completed in compliance with approved SOPs, batch records, controlled documentation, and that all applicable regulations, guidelines, safety policies and procedures are followed.90%§  Assists with process, equipment, and cleaning validation initiatives.5%Investigation§  Assists in the resolution of manufacturing deviations/non-conformances.§  Assists with troubleshooting processes and equipment.5%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  High School Diploma is required with a minimum of 0-3 years working in pharmaceutical/biopharmaceutical cGMP manufacturing environment.KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  General knowledge of cGMP, ICH guidelines, and general validation processes.§  General knowledge of cleaning and sterilization procedures for biopharmaceutical products.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Works well with others and establishes working relationships across functional departments - Quality, Facilities/Engineering/Validation, Process Validation/Development, and Manufacturing.§  Exhibits attention to detail, accuracy in work, and integrity of character.§  Self-starter, shows willingness to learn and problem-solve.§  Has technical aptitude to learn and operate production equipment.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Ability to stand for long periods of time.§  Ability to wear a sterile gown and don shoe covers on a daily basis.§  Ability to lift 40 pounds.
Endo Pharmaceuticals / Par Pharmaceutical Horsham, PA
Description Job Summary - a concise overview of the jobThe Manufacturing Associate I, Upstream Processing works in a hands-on capacity in the cGMP fermentation and production support areas to manufacture Collagenase Clostridium Histolyticum (CCH) bulk drug substance (BDS).  This role is responsible for supporting necessary fermentation and production activities, including validation and development work as needed. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Fermentation and related manufacturing operations. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeManufacturing and Compliance§  Performs daily fermentation steps of cGMP manufacture of CCH BDS:o   Work in hands-on capacity to operate fermenters, perform seed scale-up, sterilize equipment, prepare media solutions, and clean equipment as required.o   Ensures all work is completed in compliance with approved SOPs, batch records, controlled documentation, and that all applicable regulations, guidelines, safety policies and procedures are followed.90%§  Assists with process, equipment, and cleaning validation initiatives.5%Investigation§  Assists in the resolution of manufacturing deviations/non-conformances.§  Assists with troubleshooting processes and equipment.5%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  High School Diploma is required with a minimum of 0-3 years working in pharmaceutical/biopharmaceutical cGMP manufacturing environment. KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  General knowledge of cGMP, ICH guidelines, and general validation processes.§  General knowledge of cleaning and sterilization procedures for biopharmaceutical products.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Works well with others and establishes working relationships across functional departments - Quality, Facilities/Engineering/Validation, Process Validation/Development, and Manufacturing.§  Exhibits attention to detail, accuracy in work, and integrity of character.§  Self-starter, shows willingness to learn and problem-solve.§  Has technical aptitude to learn and operate production equipment.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Ability to stand for long periods of time.§  Ability to wear a sterile gown and don shoe covers on a daily basis.§  Ability to lift 40 pounds.
Endo Pharmaceuticals / Par Pharmaceutical Horsham, PA
Description Job Summary - a concise overview of the job The QC Analyst I – Microbiology will perform microbiological testing, release of in-process, intermediates and finished products, and testing for validation purposes. This role completes appropriate documentation to support testing procedures including data capture forms, equipment logbooks, and inventory forms.  Additionally, this role is responsible for assisting with the writing of standard operating procedures (SOPs) and revision of existing documentation.All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Quality Control (QC) Microbiology Department. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeSample Collection & Testing§  Conducts routine and non-routine analysis of environmental samples, raw materials, in process, and finished products according to SOPs.§  Reports identified abnormalities to QC Management for resolution and response.§  Adheres to Company safety procedures and guidelines on a daily basis.65%Documentation§  Completes appropriate documentation to support testing procedures including data capture forms, equipment logbooks, and inventory forms.20%Instrument Maintenance§  Calibrates and maintains laboratory equipment according to SOPs.5%Technical Writing§  Responsible for assisting with writing new SOPs or revising existing documentation.§  Under supervision, writes Deviation Investigations (DI’s), Laboratory Assessments (LA’s), and Investigation Reports (IR’s).5%GMP Compliance§  Applies knowledge of Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) on a daily basis.§  Adheres to Company safety procedures and guidelines on a daily basis.5%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  B.S. in a Biological Science or related field with a minimum of 0-3 years’ experience in pharmaceutical or biotechnology industry required.§  Microbiology testing experience in a pharmaceutical or biotechnology industry required.§  General experience in a development, quality, or manufacturing environment preferred. KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Functional and technical knowledge of microbiology testing (i.e., USP Purified Water, WFI, Nitrogen, Compressed Air, Environmental Monitoring, bioburden, endotoxin, TOC).§  General knowledge of cGMP practices, ICH requirements, stability, and validation.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Strong verbal and communication skills required.§  Proficient in common software applications.§  Ability to handle multiple priorities in a fast paced environment.§  Demonstrates excellent interpersonal skills and flexibility.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Lifting up to 40 lbs.§  Able to climb ladder for sampling.§  Able to stand for extended periods of time.§  Ability to wear a sterile gown and don shoe covers on a periodic basis. Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required. 
Endo Pharmaceuticals / Par Pharmaceutical Horsham, PA
Description Job Summary - a concise overview of the jobThe QC Analyst II - Chemistry will provide bioanalytical expertise for the Quality Control (QC) department. Key areas of focus are development and implementation of the quality aspects of late stage or marketed product strategy.  This role is involved with performing and assisting with OOS investigation and resolution.  Additionally, the Analyst II will have responsibility for coordinating the bioanalytical technology transfer from outside departments and to outside contractors. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.QC Chemistry Department. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeQCTesting/Safety§  Testing responsibilities may include RP-HPLC, SEC, KF, FT-IR, SDS-PAGE, and UV-Vis.§  Adheres to Company safety procedures and guidelines on a daily basis.60%Documentation§  Completes appropriate documentation to support testing procedures including data capture forms, equipment logbooks, and inventory forms.10%GMP Compliance§  Applies knowledge of Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) on a daily basis.10%Technical Writing & Investigations§  Assists with preparing new SOPs / test methods or revising of existing documentation.§  Performs and assists with OOS investigations, deviation response, and resolution.§  Writes Change Controls, Deviation Investigations (DI’s), Laboratory Assessments (LA’s), CAPA’s, and OOS investigation.10%Technical Transfer§  Coordinates bioanalytical technology transfer from outside departments and to outside contractors.5%Other Tasks§  Other duties as assigned by QC management.5%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  B.S. in a Biological Science or related field with a minimum of 3-5 years’ experience in pharmaceutical or biotechnology industry required OR§  M.S. in a Biological Science or related field with a minimum of 1-3 years’ experience in pharmaceutical or biotechnology industry.§  General experience in a development, quality, or manufacturing environment preferred.KnowledgeProficiency in a body of information required for the job   e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Working knowledge in protein chemistry and standard analytical techniques used in the biopharmaceutical industry (e.g., HPLC, FT-IR, SDS-PAGE, UV-Vis, IEF, Capillary Electrophoresis, ELISA).§  Working knowledge of cGMP practices, ICH requirements, stability, and validation required.§  Understanding of basic statistical analysis and familiarity with the use of databases is desirable.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Strong verbal and communication skills required.§  Proficient in common software applications.§  Ability to handle multiple priorities in a fast paced environment.§  Demonstrates excellent interpersonal skills and flexibility.§  Advanced writing skills.§  Proficient in running a great number of methods.§  Apply acquired biopharmaceutical skills to projects and assignments.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Lifting up to 40 lbs.§  Able to stand for extended periods of time.
Endo Pharmaceuticals / Par Pharmaceutical Horsham, PA
Description Job Summary - a concise overview of the jobThe QC Analyst II - Chemistry will provide bioanalytical expertise for the Quality Control (QC) department. Key areas of focus are development and implementation of the quality aspects of late stage or marketed product strategy.  This role is involved with performing and assisting with OOS investigation and resolution.  Additionally, the Analyst II will have responsibility for coordinating the bioanalytical technology transfer from outside departments and to outside contractors. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.QC Chemistry Department. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeQCTesting/Safety§  Testing responsibilities may include RP-HPLC, SEC, KF, FT-IR, SDS-PAGE, and UV-Vis.§  Adheres to Company safety procedures and guidelines on a daily basis.60%Documentation§  Completes appropriate documentation to support testing procedures including data capture forms, equipment logbooks, and inventory forms.10%GMP Compliance§  Applies knowledge of Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) on a daily basis.10%Technical Writing & Investigations§  Assists with preparing new SOPs / test methods or revising of existing documentation.§  Performs and assists with OOS investigations, deviation response, and resolution.§  Writes Change Controls, Deviation Investigations (DI’s), Laboratory Assessments (LA’s), CAPA’s, and OOS investigation.10%Technical Transfer§  Coordinates bioanalytical technology transfer from outside departments and to outside contractors.5%Other Tasks§  Other duties as assigned by QC management.5%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  B.S. in a Biological Science or related field with a minimum of 3-5 years’ experience in pharmaceutical or biotechnology industry required OR§  M.S. in a Biological Science or related field with a minimum of 1-3 years’ experience in pharmaceutical or biotechnology industry.§  General experience in a development, quality, or manufacturing environment preferred.KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Working knowledge in protein chemistry and standard analytical techniques used in the biopharmaceutical industry (e.g., HPLC, FT-IR, SDS-PAGE, UV-Vis, IEF, Capillary Electrophoresis, ELISA).§  Working knowledge of cGMP practices, ICH requirements, stability, and validation required.§  Understanding of basic statistical analysis and familiarity with the use of databases is desirable.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Strong verbal and communication skills required.§  Proficient in common software applications.§  Ability to handle multiple priorities in a fast paced environment.§  Demonstrates excellent interpersonal skills and flexibility.§  Advanced writing skills.§  Proficient in running a great number of methods.§  Apply acquired biopharmaceutical skills to projects and assignments.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Lifting up to 40 lbs.§  Able to stand for extended periods of time.
Endo Pharmaceuticals / Par Pharmaceutical Malvern, PA
Description Job Summary - a concise overview of the job The Digital Enablement Manager is responsible for supporting the Digital Enablement team in partnering with the brand teams to execute brand strategies and tactics for digital/Omnichannel campaigns. This role will work with individual team members and external partners to facilitate campaign processes from beginning to end.  The Digital Enablement Manager will be a business owner of Salesforce Marketing Cloud and have hands-on responsibility as a campaign project manager. The manager will be responsible for inbound campaign documentation, prioritization, requirements gathering, and drive action and execution between various stakeholder groups. This position has vendor leadership responsibilities to support planning and execution of email campaigns and other digital initiatives. The role will require strong leadership and communication skills to manage across Brand teams, IT, Marketing Cloud Managed Services partner agency and Brand agencies to effectively implement Omnichannel campaigns and enhance digital marketing capabilities. Primary responsibilities include:·        Key collaborator on Digital Enablement team and digital strategy·        Management and oversight of development, launch and measurement of email/Omnichannel campaigns across the organization through leadership and collaboration with key stakeholders·        Ensure adherence to process, compliance, privacy and business rules throughout campaign execution·        Ownership of campaign project milestones and deadlines·        Communicate email\Omnichannel campaign requirements and deadlines for cross stream project management·        Improve processes to support maturing Omnichannel campaign strategy·        Facilitate and manage digital assets in the Veeva CRM platform including rep triggered email and assets in the Media Library·        Manage workload and prioritization for Vendor partner with Veeva CRM·        Subject Matter Expert for website tagging·        Partner with Endo IT for website tagging oversight and documentation maintenance All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Highly collaborative role to manage digital tactics across platforms involving key stakeholders from internal departments and external partners.  Position requires extensive contact with identified stakeholders to manage digital campaigns, assets and standards, identify improvement opportunities, as well as implement appropriate solutions.  Internal Business Partner Contacts§  Brand Team Members§  Commercial Excellence§  Information Technology§  Sales Training & DevelopmentExternal Contacts§  Omnichannel/Managed Services Agency§  Brand Agencies of Record§  Digital hosting service providers§  Software Vendors Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeProject Management§ Across Brand Teams,  intake campaign requirements, partner with appropriate stakeholders to gather complete documentation and determine dependencies§ Partner with appropriate stakeholders to determine what analytics are required for Campaigns and tactics and ensure the set up to accomplish the analytics is completed§ Work closely with Omnichannel partner to implement campaigns in respective systems such as Marketing Cloud and the next best action engine§ Ensure adequate testing is completed for emails and campaigns§ Facilitate campaign reporting and communicate associated metrics to stakeholders§ Provide system ownership and administration for salesforce Marketing Cloud§ Salesforce Marketing Cloud specifically:o   Advise on best practices around email delivery, list hygiene, opt-in process, channel utilization, A/B testing and email optimization.o   Work with Brand Teams for any tactics that utilize salesforce Marketing Cloudo   Work with agencies to obtain email assets to incorporate into SFMC 70%Digital Asset Management§ Assist with Digital Asset Management concepts and practices in campaigns § Facilitate and manage digital assets in the Veeva CRM platform including rep triggered email and assets in the Media Library 20%Data Quality§ Work with all business partners and required vendors to support the data collection and reporting requirements associated with but not limited to US Federal Open Payments.§ Ensure Privacy guidelines are met10%Total100% QualificationsEducation and ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Bachelor's Degree in a relevant field required; advanced degree preferred.  §  7+ years of experience in Sales, Marketing and/or Commercial Operations is required.§  Prior digital marketing project management experience is required. §  Prior experience working on teams focused on developing efficient and effective operational processes and technology is required.§  Extensive experience managing third-party providers is required.§  Experience successfully evaluating and implementing technology to improve efficiency and productivity.§  Proven track record of advising stakeholders and effectively influence business partners and peers is critical. KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§ Strong knowledge of Commercial / Marketing Operations specifically Digital Marketing§ Strong knowledge of Salesforce Marketing Cloud and Marketing Automation§ Strong knowledge of Commercial and Compliance Operations is preferred: Medical, Legal, Regulatory Review process, SFA, Reporting, Analytics§ Strong knowledge of Pharmaceutical data is preferred  SkillsandAbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Ability to scenario plan, analyze data, and translate business requirements into actionable capabilities.  §  Must demonstrate personal accountability for driving company growth initiatives in a structured and compliant manner. §  Advanced proficiency with all MS Office applications, MS Project and/or Visio preferred. Leadership§  Ability to define and communicate strategic digital operational process and champion change management through the organization with multiple stakeholders.§  Demonstrated ability to exercise independent judgment, handle confidential information with discretion and effectively collaborate with multiple functional units. §  Demonstrated project management / execution skills and the ability to work on multiple projects simultaneously with little or no supervision under tight deadlines. §  Demonstrated initiative and strong problem-solving skills, including the ability to quickly assess critical situations, identify root cause of issues, anticipate needs and develop practical, meaningful solutions. §  Proactively stays current on industry trends and regulatory guidelines. Builds a Collaborative Culture§  Builds and models a culture of questioning and constructive challenge to foster openness and candid dialogue.§  Listens to and carefully considers others’ perspectives, especially to manage and resolve conflict.§  Acts with an understanding and sensitivity to others. §  Encourages accountability and responsibility that enables others to act with integrity. Leads with Agility§  Recognizes opportunities and challenges and modifies strategy accordingly.§  Moves easily between addressing current needs and planning for the future with informed insight. §  Considers marketplace and economic forces and trends in making sound business decisions. Navigates Change§  Decides and acts, even when faced with uncertainty.§  Clearly communicates the need for change and is actively responsive to the resistance it can evoke.§  Anticipates and proactively addresses the conflict and ambiguity inherent in change.§  Quickly focuses on the critical issues while prioritizing current work.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  This is a headquarters-based position that will require moderate travel (less than 10% of time).
Endo Pharmaceuticals / Par Pharmaceutical Malvern, PA
Description Job Summary - a concise overview of the jobThe Sr. Manager, Consumer Digital Marketing is the Direct to Consumer (DTC) digital marketing leader advancing capabilities and maximizing the performance of external partners across the Medical Therapeutics portfolio of products for Endo Pharmaceuticals. This role shapes, monitors, executes, and optimizes digital execution inclusive of web, SEO/SEM, database marketing/omnichannel management, social media, mobile and display advertising campaigns. As a part of the Consumer Marketing team, this role helps generate insights in order to drive ongoing optimization of brand campaigns and continual alignment of plans & strategies with brand objectives, goals and budgets. The Sr. Manager, Consumer Digital Marketing will work successfully with cross-functional internal and external teams to develop and implement research-based content strategies that bridge the customer need and the business goals.  This role requires demonstrable experience designing digital marketing strategy with a clear knowledge of integrated ecosystems, to compliment all areas of potential engagement with consumers and in support of HCP engagement. The Sr. Manager, Consumer Digital Marketing is responsible for creating strategic and innovative digital programs to improve consumer engagement through integrated digital, mobile, and social platforms, by driving the adoption of digital experiences through these initiatives. This role evolves, promotes and grows the company’s digital footprint to drive desired behavior change. The individual must be adept in implementing new and existing digital marketing efforts for the Endo Medical Therapeutics Brand Teams.  The position will also be responsible for providing ongoing education, best practice sharing, and new opportunities to the Endo enterprise Consumer Marketing teams. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Responsible for Commercial Business. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeTactical Execution & Analytics§  Defines vision, strategy and implementation of digital marketing solutions that will improve the consumer experience (CX). §  Coordinates with brand teams to plan and execute consumer media ecosystem to optimize the user funnels to drive demand.§  Provides strategic guidance on optimal multichannel engagement activities to drive growth based on specific brand and BU needs.§  Designs and champions an integrated multichannel tactical plan that is aligned to business objectives, maximizes brand relevance and value.§  Works across all Medical Therapeutic products - Xiaflex for Peyronie’s Disease, Xiaflex for Dupuytren’s Contracture, Supprelin LA, and any other brands that have a digital component to develop DTC strategy and tactical plans.§  Translates brand strategies into compelling Multi Channel Marketing (MCM) plans in collaboration with the full Consumer Marketing team, brand team partners, and external agencies that are driven by analytics and insights.§  Provides clear direction for channel mix selection, content development and delivery.§  Influences the business approach to integrated multichannel management by brainstorming new and creative growth strategies.§  Advances and shares multichannel measurement plans, selecting KPIs and setting goals, targets and measurement milestones for business objectives.§  Evaluates emerging technologies and provides thought leadership and perspective for adoption where appropriate, including telemedicine.§  Develops learning & educational programs for the branded business and other marketing members on digital marketing.§  Utilizes audience research and trend analysis to develop supporting content and digital strategies.  Evaluates customer research, market conditions and competitor activities. Conducts social monitoring to identify topics and trends that impact audience interests.§  Uses strong analytical ability to define, track, and analyze end-to-end consumer experience across multiple channels and customer touch points to make recommendations. Builds relevant KPI’s and metrics into campaigns.  Presents high-level analytics and identifies areas for optimization.§  Monitors changes in digital marketing platforms and makes recommendations for adjustments as needed.§  Responsible for monitoring campaign performance and outputs to provide timely recommendations to facilitate optimization.§  Reviews standard KPI reports to monitor performance of campaigns/ tactics and conducts cross-agency campaign performance discussions.§  Identifies key performance ‘trend breaks’ / unexpected changes based on standard reports and develops supporting hypotheses.§  Shares insights based on behavioral and performance data to assess campaign lift and ROI.§  Works with marketers to assess the MCM landscape and identifies new capabilities to optimize the user experience.50%Vendor Management§  Partners with vendors and agencies to ensure approaches and requirements for multichannel tactical plans are understood and interpreted appropriately for quality delivery and execution.§  Proficiently extracts & analyzes data, develops insights, and makes optimization recommendations to business partners.§  Manages digital external partners to ensure successful partnerships.§  Evaluates new external partners, in collaboration with digital marketing colleagues and internal subject matter experts, to identify potential areas for innovation and/or partner expansion30%Cross Functional Collaboration§  Works with brand and analytics team to define/refine customer segmentation, reports on data summary and advises on tracked metrics.§  Successfully partners with cross-functional teams, including marketing operations, technology, brand teams and agency partners.§  Position requires extensive contact with internal and external stakeholders to assess the business need, identify opportunities, and implement solutions.20% Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Bachelor’s degree in Marketing or a related field is required.§  Advanced Degree - Masters or MBA is preferred.§  8+ years of work experience in digital marketing within a highly regulated environment, ideally within the pharmaceutical industry.§  Demonstrated experience in search engine optimization, paid search, omnichannel marketing, website development, email, social media and display advertising campaigns.  Experience in Salesforce Marketing Cloud, Google Analytics, and Google AdWords is desired.§  Experience in optimizing user funnels.§  Demonstrated experience in digital analytics.§  Experience navigating telemedicine landscape for integration into marketing efforts.§  Proven experience advising stakeholders and effectively influencing business partners and peers is critical.§  Previous experience managing people. KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Advanced MCM strategy & industry expertise through ongoing training and development.§  In depth understanding of the multiple channels of customer engagement utilized by an organization across their varied customers (i.e., HCP, consumer, patient, payer) including how channels can be utilized effectively in an integrated fashion to deliver cross-channel customer journeys.§  Strong knowledge of website and advertising analytics tools, staying up to date with the latest trends & best practices in online marketing and measurement.§  Expertise in digital media planning and execution, staying up to date on landscape trends and shifts in best practices§  Knowledge of the telemedicine landscape, evolving patient dynamics, and ability to integrate into marketing initiatives.Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Advanced proficiency with all MS office applications.§  Strong analytical skills and data-driven thinking.o   Ability to utilize Google Analytics to provide insights that drive optimization and strong brand strategic and tactical planning.§  Strong consultative/listening skills with the ability to work cross-functionally in a matrixed organization.§  Ability to scenario plan, analyze data and translate business requirements into actionable plans.§  Builds and models a culture of curiosity to foster openness and candid dialogue.§  Consistently collaborates with colleagues towards a common goal with no hidden agendas.  Works hard and supports others.§  Clearly communicates the need for change and is responsive to the resistance it can evoke.§  Generates break through solutions and enables others to do the same.§  Draws on unexpected innovative and/or seemingly unrelated ways of thinking.§  Operates from a framework of possibility.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  This is a headquarters (Malvern, PA/virtual) based position that will require minimal travel (less than 10%).
Endo Pharmaceuticals / Par Pharmaceutical Malvern, PA
Description Job Summary - a concise overview of the jobThe Commercial Information Senior Manager, is a member of the commercial information management team supporting Endo’s Medical Therapeutic and Aesthetics; Sales, Marketing and Analytic functions.  This role provides business “ownership” of several outsourced commercial functions including; Veeva CRM/Sale force, customer data management, and regularly interfacing with Endo’s offshore team around our MDM/RELTIO environment. In addition, responsibilities will also include sample management related activities. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.This individual will be an individual contributor as a member of the Commercial Information team and have primary responsibility for multiple outsourced Commercial Systems/Functions. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of Time Veeva (CRM)§  Interface with Veeva Managed Services, internal IT, compliance, legal partners and end-use sales and medical division leaders.  Oversee on-going operations as well as the deployment of new commercial capabilities§  Management of Veeva CRM configuration and development on the Force.com Platform§  Fully understand end user needs and translate into technical requirements and solutions§  Lead the training and presenting of new CRM concepts and projects to internal stakeholders, end users, and new hires§  Project management lead of CRM strategies; from requirements phase, UAT, Training, Implementation, and Reporting§  Manage affiliated third party vendors as it relates to ongoing CRM capabilities in day-to-day and ongoing project functions40%MDM/CDW§  Provide operations support responsible for the maintenance of commercial master data management of HCPs, HCOs and Affiliations, data sources, data governance and stewardship§  Along with MDM service provider, responsible for the oversight of all customer match/merge rules and other data management business rules§  Regularly interface with Endo’s offshore data stewardship team managing HCP and HCO customer information within an MDM/RELTIO environment§  Provide management support for critical data related projects§  Ensure the proper use of Endo’s commercial data for both vendors and internal business partners§  Accountable for data quality across the commercial information ecosystem§  Ensure the proper level of data capture to support compliance reporting§  Partner with Endo commercial data leadership to support our compliance management efforts as they relate to commercial information40%Sample Management§  Primary point of contact for Third Party vendors, Marketing, Sales Training, and Supply Chain supporting sampling business processes including sample allocations, sample orders, sample SOPs sample training documents, Sales Representative Training as it relates to Endo Medical Therapeutics and Aesthetics business §  Interface with internal stakeholders - IT, compliance, legal partners and end-user sales and medical division leaders§  Work with all business partners and required vendors to support the data collection and reporting requirements §  Partner with Compliance to provide insight into establishing/maintaining PDMA monitoring program§  Review monitoring reports and identify any PDMA potential gaps and/or risks§  Provide recommendations for improving PDMA compliance§  Clear understanding of the translation of PDMA CFR Part 11 to field technology §  Strong knowledge of key laws and regulations impacting the pharmaceutical industry including the PhRMA Code; (PDMA)§  Primary support for sales field teams for all sample related activities §  Provide Finance with end of month sample utilization reports20%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  A Bachelor’s Degree required with 3-5 years’ relevant experience in the following:§  Commercial Information management within the US Pharmaceutical industry§  Primary experience working with Veeva, all modules, developing business requirements to meet emerging business needed§  Vendor or Third Party Management Experience required§  Pharmaceutical industry experience is required specifically working with commercial systems§  Veeva/Salesforce admin certification highly preferred§  BI Tool Experience (Tableau, SQL) strongly desired§  Experience with both offsite and offshore vendor management a plus§  Experience with end-to-end CRM implementations as a lead/core contributor    KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Expertise in configuring Veeva CRM and development on the Force.com Platform§  Clear understanding of the translation of PDMA CFR Part 11 to field technology §  Strong knowledge of key laws and regulations impacting the pharmaceutical industry including the PhRMA Code; (PDMA)§  Strong working knowledge of MS Office products (e.g. Excel, Word, and PowerPoint).§  Understanding of Commercial data and how to present the data in a meaningful way§  SFMC activities as it relates to Omni Channel Marketing initiatives §  Knowledge of Sample Operations / Sample Compliance/ Sample Management / Accountability / PDMA within Pharma§  Knowledge of Commercial Data Warehousing and Master Data Management concepts and functionsSkills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Strong oral and written skills with the ability to direct discussion with confidence and conviction in order to drive business decision-making and actions§  Must have ability to influence without authority§  Be able to work in a highly matrixed environment with external suppliers and internal stakeholders§  Ability to gather and translate business requirements into digital technology solution and implement in an accurate, efficient and reliable manner§  Ability to identify challenges in existing processes and perform in a dynamic environment to develop actionable solutions and define process improvements§  Ability to interpret, articulate, and present complex customer concepts to varying audiences (Sales Leadership, Compliance, IT, Insights and Analytics, Marketing)Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Ability to sit in an office environment§  Possibility of partial or full remote work§  Be able to travel to business meetings as required, may entail air travel and multi-day meetings. Up to 5% of the time
Endo Pharmaceuticals / Par Pharmaceutical Malvern, PA
Description Job Summary - a concise overview of the job Management of regulatory activities for all projects assigned to the CMC group.  Ensure regulatory conformance for commercial products through effective change management.  Maintain a high level understanding of global regulatory requirements and anticipate the impact of the changing regulatory environment on development and registration strategy.  Manage budget associated with group activities and provide regulatory strategy for life-cycle management.  Provide regulatory support for due diligence activities associated with the assessment of business opportunities; the development of biologics and the submission of INDs and BLAs; the development of drug products and combination products and Medical Devices. All incumbents are responsible for following applicable Division & Company policies and procedures.Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.Regulatory Affairs activities for the CMC group. Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeBusiness OperationsManagement of all regulatory activities for development and commercial projects assigned to the group:§  Act or assign a regulatory representative for each project team.§  Oversee the development and implementation of regulatory submission strategy.§  Manage the planning, preparation and technical review of regulatory submissions and ensure submissions are completed to meet required/established timelines.§  Collaborate on the development and/or optimization of product development strategy to be consistent with regulatory requirements. §  Interact with regulatory authorities to address regulatory strategy, milestone meetings, queries and regulatory actions.§  Will be a hands-on manager, and can cover for and execute on work themselves if staff members need aid or are on temporary leave.50%Business Strategy§  Maintain a high level understanding of global regulatory requirements including those for filing and approval of investigational and commercial products.§  Provide regulatory guidance and strategy for life-cycle management planning and development for commercial products.§  Anticipate the impact of the changing regulatory environment on development plans and registration strategy. Develop and implement strategies to proactively influence/address these changes.25%Compliance§  Ensure regulatory conformance for commercial products through effective change management.15%Fiscal Discipline§  Manage budget associated with group activities including submission fees (ex-US), business travel and training.5%Due Diligence§  Provide regulatory support for due diligence activities associated with the assessment of business opportunities.5%Total100% QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and  certifications required for the job§  Graduate degree in a scientific/technical discipline (Ph.D., MS Science or PharmD.) with a minimum 10 years’ pharmaceutical drug development experience and 7 years’ hands-on regulatory experience.§  Proven track record in new chemical entity and line extension regulatory filings, approvals and strategic planning.§  Must have strong experience in development of biologics products and have worked on biologics INDs and BLAs.§  Strong knowledge of regulations/guidelines governing development and commercialization of pharmaceuticals, including biologics.§  Basic computer skills (MS Office, Excel and Adobe Acrobat).§  Experience supporting and conducting due diligence activities. KnowledgeProficiency in a body of information required for the job    e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.§  Strong knowledge of regulations/guidelines governing pharmaceutical/biologics development is required.§  Familiarity/understanding of FDA regulatory processes (experience with ex-US regulatory authorities/processes is desired).Skills&AbilitiesOften referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.§  Ability to communicate clearly and concisely with senior management and regulatory authorities.§  Ability to multi-task in a fast-paced atmosphere with multiple/changing priorities.§  Experience managing multiple headcount and developing/mentoring junior staff.§  Ability to effectively delegate tasks and hold others accountable.Physical RequirementsPhysical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.§  Occasional business travel.