Quality Control Microbiology Principle Scientist

Summary

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.

Duties & Responsibilities

Technical Expertise & Testing

• 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.

Method Transfer, Validation & Documentation

• 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.

Regulatory Compliance & Quality Systems

• 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.

Projects, Continuous Improvement & Leadership

• 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.

Mentorship & Communication

• 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.

Qualifications

Education

• Bachelor's degree in a STEM field, Microbiology preferred

Experience

• 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.

Additional information

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview

Bothell - WA - US: $133,280 - $161,504

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including 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 also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

How We Work

• Where you work matters – because collaboration, innovation and patient impact happen in many settings.
• Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design.
• The model assigned to this role is based on its core responsibilities.

Data Protection

• We will never request payments, financial information, or social security numbers during our application or recruitment process.
• Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

• If this posting is missing required information required by local law or incorrect, contact BMS at the Job Title and Requisition number.
• Do not send application-related inquiries to this email.
• To check your application status, please login to your Candidate Home Account.

R1606225: Quality Control Microbiology Principle Scientist