Senior Principal Scientist, Analytical Chemistry

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Our 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, this team uses 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. Our team is involved at the earliest stages of pharmaceutical and biopharmaceutical product development through successful commercial launch.

The Senior Principal Scientist will serve as a CMC Analytical Lead (CMC-AL) 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. 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.

The role drives analytical controls in alignment with ICH guidelines and global regulatory requirements and has significant influence across the division and broader organization.

The Senior Principal Scientist will primarily be an individual contributor and leader of a matrix team of analytical scientists, and a core member of the CMC team. The Senior Principal Scientist will collaborate across BMS sites with functional Analytical Leads, Drug Substance and Drug Product Leads, Quality Lead, and Regulatory Lead to generate and execute analytical strategies to ensure product quality.

• 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…