Quality Control Microbiology Principal Scientist

Bristol Myers Squibb • Bothell, WA

1d • Onsite

About The Position

The Quality Control (QC) Microbiology Principal Scientist (EG 120) serves as a subject matter expert (SME) across microbiological test methods and processes, supporting multiple products throughout their lifecycle. The primary focus of this role is to support GMP testing for product release, in-process testing, and transfer/validation activities, while applying a high level of technical knowledge, scientific principles, and regulatory acumen to drive quality outcomes. This position independently leads and executes method transfers, validations, and verifications, and is responsible for authoring and reviewing associated protocols, reports, and GMP documentation in alignment with regulatory and corporate guidelines. The QC Microbiology Principal Scientist plays a key role in investigations, deviations, CAPAs, and continuous improvement efforts, and actively represents the QC department in cross-functional teams, product review boards, and both internal and external regulatory inspections.

Requirements

• Bachelor's degree in a STEM field, Microbiology preferred
• 10+ years of relevant cGMP experience, preferably in biotechnology, cell therapy, or an equivalent regulated environment.
• Equivalent combination of experience and education will be considered.
• Demonstrated ownership of cross-functional quality programs and systems (change control, document lifecycle, deviations/CAPA, risk assessments) and effective project management driving deliverables to completion.

Responsibilities

• Serve as a recognized subject matter expert for microbiological test methods and processes across multiple products and product stages.
• Reviews GMP testing in support of product release, in-process testing, and stability programs for both complex and non-complex methods on intermediate and finished products.
• Reviews Microbial Identifications of environmentally isolated organisms using MALDI-TOF technology and other microbiological platforms.
• Apply technical knowledge, regulatory requirements, and scientific principles to independently anticipate, troubleshoot, and problem-solve non-routine and complex microbiological issues.
• Lead and execute method transfers, validations, and verifications of in-process, final product, and stability methods.
• Independently develop, write, and execute methods, protocols, reports, and other related GMP documents aligned with applicable regulatory and corporate guidelines.
• Perform data verification, data review, and review of GMP documentation to ensure accuracy, completeness, and compliance.
• Utilize LIMS, ELN, and laboratory data analysis systems to manage, analyze, and report data.
• Understand, follow, interpret, and accurately apply Global Regulatory and cGMP requirements across all responsibilities.
• Represent the QC department in product review boards and regulatory inspections, both internal and external audits.
• Author and contribute to responses to regulatory requests and health authority inquiries.
• Review and approve laboratory investigations and deviations, ensuring thorough root cause analysis and appropriate corrective actions.
• Lead and contribute to the development of CAPAs, change controls, and document revisions in support of quality systems.
• Own and contribute meaningfully to complex change controls.
• Conceptualize and lead complex projects, change controls, and continuous improvement (CI) initiatives that enhance laboratory efficiency, compliance, and data integrity.
• Actively participate in and lead Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives within the team.
• Identify and escalate challenges and barriers to execution, propose solutions, and drive remediation efforts to resolution.
• Champion and foster a positive, collaborative, and supportive quality culture within the team and across the organization.
• Represent QC interests on cross-functional and cross-site teams, maintaining alignment with broader organizational objectives.
• Mentor laboratory colleagues on multiple QC microbiological test methods, processes, and procedures.
• Communicate effectively and professionally with peers, department management, and cross-functional partners.
• Author and review technical documents, standard operating procedures (SOPs), and scientific communications with a high degree of accuracy and clarity.
• Ability to prioritize, manage workload, and meet deadlines in a fast-paced, dynamic team environment.

Benefits

• wellbeing support
• retirement and financial protection benefits
• insurance offerings (medical, dental, vision, life and disability)
• Flexible Time Off (FTO)
• 11 paid company holidays
• 160 hours of paid vacation annually for new hires
• 3 optional holidays
• paid sick leave
• up to two paid volunteer days per year
• summer hours flexibility
• leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
• annual Global Shutdown between Christmas Day and New Year's Day

What This Job Offers

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