Senior Principal Scientist

Bristol Myers Squibb • Seattle, WA

5d • $175,166 - $183,690 • Hybrid

About The Position

Bristol-Myers Squibb Company is hiring a(n) Senior Principal Scientist (in Seattle, WA). This role involves using technical knowledge to support the development of cellular drugs within the Chemical Manufacturing Control (CMC) program. The Senior Principal Scientist will act as a resource for the Cell Therapy Analytical Development department, supporting product release, characterization, and in-process testing of cellular drug products. The position requires preparing actionable strategies to align with business objectives, implementing analytical strategies for successful project execution, and collaborating with various teams to build cellular processes. Additionally, the role includes conducting drug product analytical risk identification, assessment, and mitigation, justifying drug product specifications for clinical programs, and serving as an author for analytical sections of CMC submissions, including responding to regulatory questions. Telecommuting is permitted up to 2 days per week.

Requirements

• Master’s degree or foreign equivalent degree in Biochemistry, Molecular Biology, or a related field.
• Four (4) years of work experience as a Medical Scientist or related occupation.
• Four (4) years of experience in developing Chemistry, Manufacturing, and Controls (CMC) analytical strategies for cell and gene therapy products and biologics products.
• Four (4) years of experience utilizing gene editing technologies such as CRISPR-Cas9 to create engineered T-cells.
• Four (4) years of experience analyzing large datasets for multiple clinical cellular products.
• Four (4) years of experience drafting technical regulatory filings including Investigational New Drug (IND) amendments, Biologics License Applications (BLAs), briefing books, and regulatory responses.
• Four (4) years of experience developing and transferring cellular or biologics analytical methods that are suitable for use in QC or characterization of product.

Responsibilities

• Use technical knowledge to support the development of cellular drugs in the Chemical Manufacturing Control (CMC) program.
• Act as a resource for the Cell Therapy Analytical Development department in support of product release, characterization, and in-process testing of cellular drug products.
• Prepare actionable strategies to ensure alignment with business objectives.
• Implement analytical strategy to ensure successful project execution.
• Collaborate with various teams to build cellular process.
• Conduct DP analytical risk identification, assessment, and mitigation.
• Justify drug product specifications for clinical programs.
• Serve as an author for analytical sections of CMC submissions and respond to regulatory questions.

Benefits

• Annual discretionary bonus
• Healthcare: 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: Flexible time off (unlimited, with manager approval), 11 paid national holidays (with exceptions), 160 hours annual paid vacation for new hires (with manager approval), 3 optional holidays.
• 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