Senior Principal Scientist, Analytical Chemistry
Listed on 2026-07-09
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Pharmaceutical
Regulatory Compliance Specialist, Pharmaceutical Science/ Research
Working with Us is challenging, meaningful, and life‑changing. At Bristol Myers Squibb, unique and impactful work happens daily across all departments.
Team OverviewOur Analytical Science and Operations team creates transformative medicines for tomorrow based on the cutting‑edge science of today. Working within Global Product Development and Supply, we use state‑of‑the‑art technologies to develop, enable and execute analytical and CMC strategies that ensure safety, quality and efficacy of life‑saving medicines administered to patients in clinical studies.
Position SummaryThe Senior Principal Scientist will serve as a CMC Analytical Lead (CMC‑AL) for drug candidates across all stages of development, and for the commercial portfolio as needed. As a key member of cross‑functional CMC teams, the incumbent will collaborate across functions to identify critical quality attributes (CQAs) for drug substance and drug product and establish control strategies to ensure product quality.
Roleand Responsibilities
- Lead analytical strategy development as a core member of cross‑functional CMC teams.
- Define product critical quality attributes and 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.
- Author, review, and approve technical reports to support regulatory submissions.
- Respond to regulatory authority questions related to analytical strategy and data.
- Provide leadership, coaching, and mentoring to scientific staff within matrix teams.
- 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.
- Strong communication and interpersonal skills.
- Experience working in matrixed team environments.
- Familiarity with modern laboratory equipment and automation.
- Knowledge and application of Quality by Design (QbD) principles.
New Brunswick,NJ–US: $135,950–$164,738. The starting compensation range is for a full‑time employee. Additional incentive cash and stock opportunities (based on eligibility) may be available.
Benefits Overview- Health coverage: medical, pharmacy, dental, and vision care.
- Well‑being support:
Well‑Being Account, Living Life Better, Employee Assistance Programs. - Financial and retirement plans: 401(k), disability and life insurance, supplemental health, business travel protection, personal liability protection, identity theft benefit, and legal support.
- Paid time off, flexible time, national holidays, paid vacation, and other employee benefits.
BMS is an equal‑opportunity employer. All qualified applicants will receive consideration for employment.
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