Senior QC Microbiology Scientist & Method Expert

Bristol-Myers Squibb Co; Bothell (WA); On-site; USD 133,000 - 162,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Comprehensive benefits

Job summary

Bristol Myers Squibb is seeking a QC Microbiology Principal Scientist to act as SME across test methods and processes. You will support GMP testing for product release and in-process work, lead method transfers and validations, and author GMP documents with regulatory alignment.

You will also drive investigations, CAPAs, and continuous improvement within an integrated QC team. The role requires extensive cGMP experience, strong regulatory knowledge, and leadership in cross-functional settings,

Qualifications

• Bachelor’s degree in a STEM field, Microbiology preferred.
• 10+ years of relevant cGMP experience, preferably in biotechnology or related regulated environment.
• Demonstrated ownership of cross‑functional quality programs and systems and effective project management.

Responsibilities

• Lead and execute method transfers, validations, and verifications for in-process, final product, and stability methods.
• Authorize and review GMP documentation, SOPs, protocols, and reports with accuracy and compliance.
• Review laboratory investigations and deviations with root-cause analysis and CAPA development.
• Represent QC in cross-functional teams and support regulatory inspections and health authority inquiries.

Skills

cGMP experience

Education

Bachelor's degree in STEM, Microbiology preferred

Tools

MALDI-TOF

Job description

Bristol Myers Squibb is seeking a QC Microbiology Principal Scientist to act as SME across test methods and processes. You will support GMP testing for product release and in-process work, lead method transfers and validations, and author GMP documents with regulatory alignment.

You will also drive investigations, CAPAs, and continuous improvement within an integrated QC team. The role requires extensive cGMP experience, strong regulatory knowledge, and leadership in cross-functional settings,