QC Microbiology Scientist - Method Transfer & Validation

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

Job summary

Bristol Myers Squibb in Bothell, WA is seeking a QC Microbiology Principal Scientist (EG 120) to serve as SME across microbiological test methods, supporting GMP testing for product release, in-process testing, and transfers. The role leads method transfers, validations, verifications, and authors GMP documents.

The successful candidate has 10+ years of cGMP experience in biotech or regulated environments, strong QA leadership, and proven ability to drive CAPAs and investigations within

Qualifications

• Bachelor's degree in a STEM field, Microbiology preferred.
• 10+ years of relevant cGMP experience in biotech or regulated environments.
• Ownership of cross-functional quality programs (change control, document lifecycle, deviations/CAPA) and project management.

Responsibilities

• Lead and execute method transfers, validations, and verifications.
• Develop, write, and execute GMP documents and reports.
• Review data verification and GMP documentation for accuracy and compliance.
• Utilize LIMS, ELN, and analytical systems to manage and report data.

Skills

cGMP experience

QA leadership

Method transfers

Regulatory compliance

CAPA management

Education

Bachelor's degree in STEM

Microbiology preferred

Tools

LIMS

ELN

MALDI-TOF

Job description

Bristol Myers Squibb in Bothell, WA is seeking a QC Microbiology Principal Scientist (EG 120) to serve as SME across microbiological test methods, supporting GMP testing for product release, in-process testing, and transfers. The role leads method transfers, validations, verifications, and authors GMP documents.

The successful candidate has 10+ years of cGMP experience in biotech or regulated environments, strong QA leadership, and proven ability to drive CAPAs and investigations within