Senior QC Microbiology Scientist - Method Transfers & CI

VetJobs; Bothell (WA); Presencial; USD 133 000 - 162 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

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Resumo da oferta

Bristol Myers Squibb in Bothell, WA is seeking a QC Microbiology Principal Scientist to lead microbiological testing, method transfers, and validation efforts. You will author GMP documents, participate in regulatory inspections, and drive continuous improvement within QC.

The role requires a strong cGMP background and leadership across cross-functional teams. The position emphasizes data integrity, regulatory compliance, and collaboration with internal and external stakeholders to ensure

Qualificações

• 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 such as change control, document lifecycle, deviations/CAPA.

Responsabilidades

• Serve as SME for microbiological test methods across products and stages.
• Lead method transfers, validations, and verifications of in-process and finished product methods.
• Review GMP testing for product release and stability programs.
• Author and review GMP documents, protocols, reports, and deviations with accuracy.
• Represent QC in cross-functional teams, product review boards, and regulatory inspections.
• Mentor colleagues on QC microbiology test methods and procedures.

Conhecimentos

Microbiology expertise

cGMP knowledge

Regulatory acumen

Cross-functional collaboration

Formação académica

Bachelor's degree in STEM

Ferramentas

MALDI-TOF

LIMS

ELN

Descrição da oferta de emprego

Bristol Myers Squibb in Bothell, WA is seeking a QC Microbiology Principal Scientist to lead microbiological testing, method transfers, and validation efforts. You will author GMP documents, participate in regulatory inspections, and drive continuous improvement within QC.

The role requires a strong cGMP background and leadership across cross-functional teams. The position emphasizes data integrity, regulatory compliance, and collaboration with internal and external stakeholders to ensure