Senior Principal Scientist, Analytical Chemistry

Bristol Myers Squibb • New Brunswick, NJ

4d • Onsite

About The Position

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.

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.

Nice To Haves

• 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.

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.

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.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include 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 and an annual Global Shutdown between Christmas and New Years Day.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed