QC Microbiology Scientist, Cell Therapy Method Transfer

Biopharma Careers

Harvard (MA)

On-site

USD 99,000 - 120,000

Full time

7 days ago
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Benefits offered by this job

Comprehensive benefits
Flexible time off
Vacation and holidays

Job summary

Bristol Myers Squibb in Devens, MA is seeking a Scientist for QC Microbiology in Cell Therapy. You will expertly support method transfer/verification, perform routine testing of in-process and final products, and lead deviations/investigations with CAPA.

You will mentor staff and ensure GMP compliance across multiple methods and products. The role demands 6+ years of microbiology QC experience and strong technical writing, with opportunities for career growth in a collaborative, patient-focused

Qualifications

  • Bachelor’s degree or equivalent required, preferably in science. Advanced degree preferred.
  • 6+ years of relevant microbiological testing or QC experience or equivalent.
  • Demonstrated experience with microbiological techniques.
  • Ability to follow Global Regulatory and cGMP requirements.
  • Demonstrated technical writing skills.
  • Strong problem-solving ability and logical thinking.
  • Excellent communication with peers and management.
  • Ability to work in a fast-paced team and prioritize multiple projects.
  • Knowledge of LIMS, ELN and lab data analysis systems is a plus.
  • Strong mentoring and interpersonal skills.

Responsibilities

  • Subject matter expert supporting method transfer/verification/validation and routine testing of in-process, final product, and stability samples.
  • Review testing data packets, final lot files, COA reviews.
  • Perform complex troubleshooting and independent problem solving.
  • Review GMP documentation for multiple methods/products.
  • Own CAPA and deviation/investigation tasks and continuous improvement.
  • May represent the department in regulatory inspections.
  • Train and mentor others on QC test methods and procedures.
  • Cross-train on multiple complex microbiology methods and products.
  • Write and revise technical documents such as test methods and SOPs.
  • Perform other tasks as assigned.

Skills

Microbiology techniques
Technical writing
Communication
Problem solving

Education

Bachelor's degree or equivalent
Advanced degree preferred

Tools

LIMS
ELN
Laboratory data analysis

Job description

Bristol Myers Squibb in Devens, MA is seeking a Scientist for QC Microbiology in Cell Therapy. You will expertly support method transfer/verification, perform routine testing of in-process and final products, and lead deviations/investigations with CAPA.

You will mentor staff and ensure GMP compliance across multiple methods and products. The role demands 6+ years of microbiology QC experience and strong technical writing, with opportunities for career growth in a collaborative, patient-focused

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