Quality Control Microbiology Principal Scientist

Scorpion Therapeutics; Bothell (WA); On-site; USD 150,000 - 210,000; Full time

Job summary

Bristol Myers Squibb is seeking a microbiology SME to support GMP testing and lifecycle management of biopharmaceutical products. You will lead method transfers, validations, verifications and author GMP documents.

You will investigate deviations, act as QC representative in audits, drive continuous improvement, mentor colleagues, and manage data in LIMS/ELN. 10+ years of cGMP experience and a Bachelor's in STEM are required.

Qualifications

• Bachelor's in STEM (microbiology preferred).
• 10+ years of cGMP experience in biotechnology, cell therapy, or similar regulated setting.
• Proven expertise in microbiological testing, regulatory compliance, and quality systems.
• Prior ownership of cross-functional programs and project management skills.

Responsibilities

• Lead method transfers.
• Perform validations and verifications.
• Author and review GMP documentation.
• Investigate deviations and CAPAs.
• Represent QC in audits and regulatory inspections.
• Drive continuous improvement initiatives and mentor colleagues on microbiological methods.
• Manage data using LIMS and ELN systems.

Skills

Microbiology

Regulatory compliance

Quality systems

Cross-functional program ownership

Project management

Education

Bachelor's degree in STEM

Job description

Role

Serve as a microbiology SME supporting GMP testing and lifecycle management of biopharmaceutical products at Bristol Myers Squibb.

Responsibilities

• lead method transfers
• validations
• verifications
• author and review GMP documentation
• investigate deviations, deviations, and CAPAs
• represent QC in audits and regulatory inspections
• drive continuous improvement initiatives
• mentor colleagues on microbiological methods
• manage data using LIMS and ELN systems

Requirements

• Bachelor's in STEM (microbiology preferred)
• 10+ years of cGMP experience in biotechnology, cell therapy, or similar regulated environment
• proven expertise in microbiological testing, regulatory compliance, and quality systems
• prior ownership of cross-functional programs and project management skills

High-Value

microbiology, GMP testing, method validation, microbiological investigations, regulatory audits, biotech or cell therapy products, lifecycle support.