Senior QC Microbiology Specialist — Cell Therapy

Bristol Myers Squibb; Harvard (MA); On-site; USD 60,000 - 73,000; Full time

Job summary

Bristol Myers Squibb is seeking a QC Senior Specialist for QC Microbiology at the Cell Therapy Facility (CTF) in Devens, MA. The QC Senior Specialist is responsible for supporting Quality Control microbiology testing for release of clinical and commercial cell therapy drug products.

This role interfaces with multiple groups and requires independent task execution, interpretation of results, and troubleshooting.

Qualifications

• Bachelor’s degree required, preferably in Science.
• 4+ years of relevant work experience, preferably in a regulated environment.
• Experience in GMP laboratory, preferably with cell therapy products.
• Knowledge of aseptic technique within a laboratory environment.
• Hands on experience with various microbiology techniques including PCR, endotoxin and sterility testing.
• Ability to understand and apply Global Regulatory and cGMP requirements.
• Strong technical writing skills and cross-functional communication.
• Working knowledge of LIMS and data analysis systems is desirable.

Responsibilities

• Perform compendial verification, method transfer/validation, and routine testing of in-process, final product, and stability samples.
• Use scientific principles to assist with microbiological testing methods and proper laboratory equipment usage (Sterility, Bioburden, Endotoxin, Environmental monitoring).
• Anticipate and troubleshoot problems.
• Train new analysts and become a qualified trainer on assigned assays.
• Deliver training to analysts and document training per cGMP requirements.
• Support document revision, CAPA, investigations/deviation tasks.
• Perform tasks within CAPA, deviation, or project scopes.
• May lead projects and continuous improvement efforts.
• Other duties as assigned and may include shift coverage.

Skills

Strong written communication

Technical writing

Problem solving

Cross-functional collaboration

Detail oriented

Education

Bachelor’s degree

Tools

LIMS

Data analysis systems

PCR

Endotoxin testing

Sterility testing

Job description

Bristol Myers Squibb is seeking a QC Senior Specialist for QC Microbiology at the Cell Therapy Facility (CTF) in Devens, MA. The QC Senior Specialist is responsible for supporting Quality Control microbiology testing for release of clinical and commercial cell therapy drug products.

This role interfaces with multiple groups and requires independent task execution, interpretation of results, and troubleshooting.