Quality Control Microbiology Principle Scientist

Bristol Myers Squibb • Bothell, WA

5d • $133,280 - $161,504

About The Position

The Quality Control (QC) Microbiology Principal Scientist (EG 120) serves as a subject matter expert across microbiological test methods and processes, supporting multiple products throughout their lifecycle. The role primarily supports GMP testing for product release, in-process testing, and transfer and validation activities, applying technical expertise, scientific principles, and regulatory knowledge to deliver quality outcomes.

The Principal Scientist independently leads method transfers, validations, and verifications and authors and reviews associated protocols, reports, and GMP documentation in accordance with regulatory and corporate guidelines. The position contributes to investigations, deviations, CAPAs, and continuous improvement, and represents QC on cross-functional teams, product review boards, and internal and external regulatory inspections.

Requirements

• Bachelor's degree in a STEM field; Microbiology preferred.
• 10 or more years of relevant cGMP experience.
• Demonstrated ownership of cross-functional quality programs and systems, including change control, document lifecycle, deviations/CAPA, and risk assessments.
• Effective project management skills and ability to drive deliverables to completion.
• Equivalent combinations of experience and education will be considered.

Nice To Haves

• Experience in biotechnology, cell therapy, or an equivalent regulated environment.
• Microbiology degree or background.

Responsibilities

• Serve as a subject matter expert for microbiological test methods and processes across multiple products and product stages.
• Review GMP testing supporting product release, in-process testing, and stability programs for intermediate and finished products, including complex and non-complex methods.
• Review microbial identifications of environmentally isolated organisms using MALDI-TOF technology and other microbiological platforms.
• Independently troubleshoot and resolve non-routine and complex microbiological issues using technical knowledge, regulatory requirements, and scientific principles.
• Lead and execute method transfers, validations, and verifications for in-process, final product, and stability methods.
• Develop, write, and execute methods, protocols, reports, and related GMP documents in line with regulatory and corporate guidelines.
• Perform data verification and review, and review GMP documentation for accuracy, completeness, and compliance.
• Use LIMS, ELN, and laboratory data analysis systems to manage, analyze, and report data.
• Apply global regulatory and cGMP requirements across responsibilities.
• Represent QC in product review boards and internal and external regulatory inspections and audits.
• Author and contribute to responses to regulatory requests and health authority inquiries.
• Review and approve laboratory investigations and deviations, including root cause analysis and corrective actions.
• Lead and contribute to CAPAs, change controls, and document revisions; own and contribute meaningfully to complex change controls.
• Lead complex projects and continuous improvement initiatives that enhance laboratory efficiency, compliance, and data integrity.
• Participate in and lead Operational Excellence and Continuous Improvement initiatives.
• Identify and escalate execution challenges and barriers, propose solutions, and drive remediation to resolution.
• Promote a positive, collaborative, and supportive quality culture within the team and organization.
• Represent QC on cross-functional and cross-site teams and maintain alignment with organizational objectives.
• Mentor laboratory colleagues on QC microbiological test methods, processes, and procedures.
• Communicate effectively and professionally with peers, management, and cross-functional partners.
• Author and review technical documents, SOPs, and scientific communications accurately and clearly.
• Prioritize and manage workload and meet deadlines in a fast-paced, dynamic team environment.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
• Eligible U.S.-based exempt employees receive Flexible Time Off without a set accrual limit, subject to manager approval, and 11 paid company holidays annually.
• Eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires, 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Additional discretionary incentive cash and stock opportunities may be available.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior