Process Development Scientist

Requirements

• Doctorate degree OR Master's degree and 2 years of relevant experience OR Bachelor's degree and 4 years of relevant experience
• Advanced degree in Bioanalytical Chemistry, Analytical Chemistry, Biochemistry, Biochemical or Chemical Engineering
• 3+ years pharmaceutical/biotech experience in process development and analytical method development
• Deep understanding of product quality attributes and control strategies, quality attribute assessments, and Quality Target Product Profile throughout the lifecycle of a product
• Commanding knowledge of analytical methods/technologies such as Chromatography, CE, General Assays (e.g. pH, Osmolality, Karl Fisher titration, etc.), Gels, Bioassays and Immunoassays used to test diverse modalities including monoclonal and bispecific antibodies, bispecific T-cell engagers (“BiTEs”), synthetic peptides and biosimilar products
• Analytical project leadership experience
• Strong leadership skills and ability independently lead
• Solid understanding of GMP requirements and familiarity with USP monographs and chapters, as well ICH guidance documents related to analytical method transfer and validation
• Experience with developing, implementing and commercializing methods for in-process testing, process characterization, release and stability testing
• Strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements
• Strong understanding of drug substance and drug product manufacturing processes
• Experience with regulatory filings and commercial quality systems
• Experience working closely with process engineers and quality control laboratories to generate and interpret analytical data to provide enhanced understanding and guidance around process understanding and control
• Experience with QbD and PAT, as applied to pharmaceutical development
• Experience managing and transferring commercial production and test methods
• Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
• A diplomatic approach – trusting and respectful interaction with global colleagues from a broad diversity of backgrounds – emphasis on listening
• Excellent technical writing skills and attention to detail in authoring technical reports and regulatory filing documents
• A self-starter and teammate with strong decision-making skills
• Ability to multitask, clearly plan and effectively follow through on complex deliverables

Benefits

• Comprehensive employee benefits package
• Discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements