Role OverviewThe Senior Principal Scientist will serve as a CMC Analytical Lead for drug candidates across all stages of development, as well as within the commercial product portfolio as needed. This role is a key member of cross-functional CMC teams responsible for analytical strategy development.
What You Will Do
Lead analytical strategy development, define product critical quality attributes, establish methods, specifications, and analytical control strategies, collaborate across Analytical, Drug Substance, Drug Product, Quality, and Regulatory functions, review, interpret, and communicate analytical results and conclusions.
Why It Might Be a Fit
Strong expertise in synthetic chemistry, drug substance and drug product development, extensive experience in analytical method development, validation, and technical transfer, experience with analytical testing across diverse dosage forms, knowledge of dissolution methods and biopharmaceutical assessment, familiarity with ICH and global regulatory requirements.
Requirements
- BS with 12–15 years, MS with 9–12 years, or PhD with 6–8 years of pharmaceutical experience in chemistry or related discipline
- Demonstrated scientific accomplishments including publications and presentations
- Experience with GMP and GLP requirements and risk assessment processes
- Strong expertise in synthetic chemistry, drug substance and drug product development
- Extensive experience in analytical method development, validation, and technical transfer
- Experience with analytical testing across diverse dosage forms
- Knowledge of dissolution methods and biopharmaceutical assessment
- Familiarity with ICH and global regulatory requirements
- Experience supporting regulatory submissions and building CMC dossiers
- Experience with commercialization of small molecule drug products
- Experience managing external manufacturing and testing labs
Benefits
- Health Coverage: Medical, pharmacy, dental, and vision care
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support
- Paid Time Off
- Flexible time off (unlimited, with manager approval)
- 11 paid national holidays
- 160 hours annual paid vacation for new hires with manager approval
- 11 national holidays, and 3 optional holidays
- Unlimited paid sick time
- Up to 2 paid volunteer days per year
- Summer hours flexibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- Annual Global Shutdown between Christmas and New Years Day
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