Senior Specialist, QC Microbiology, Cell Therapy
Bristol Myers Squibb
4 months ago
On-site
Devens, MA
Operations
Position Summary
Responsible for supporting QC testing for in-process, final product, stability samples, and environmental/facility monitoring (including data review/verification). Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts.
Responsibilities
- Perform method transfer/verification/validation and routine testing of in-process, final product, and stability samples; conduct environmental/facilities monitoring and microbiological testing.
- Anticipate and perform routine troubleshooting and problem-solving with minimal guidance.
- Perform data verification and data review; review GMP documentation for general and complex methods.
- Perform document revision, project, CAPA, and deviation/investigation related tasks and/or continuous improvement efforts.
- Train and mentor others on QC test methods, processes, and procedures.
- Perform other tasks as assigned.
Qualifications
- Ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
- Demonstrated technical writing skills.
- High problem-solving ability; technically adept and logical.
- Effective communication with peers, management, and cross-functional partners.
- Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
- Advanced knowledge of LIMS and ELN and laboratory data analysis systems preferred.
- Bachelor’s degree or equivalent required (preferably in science); advanced degree preferred; Netherlands: MLO level 4 required.
- 4+ years of relevant microbiological testing or QC experience (preferably in a regulated environment).
- Demonstrated experience with microbiological techniques.
Compensation (Devens, MA, US)
- $43.84–$53.12 per hour.
Benefits (high level)
- Health coverage; wellbeing support; 401(k) and insurance/disability options.
- Paid time off, flexible time off/annual vacation varies by location/employee type; additional eligible leave and Global Shutdown.
Application instructions
- Apply for the role (requisition R1601149: Senior Specialist, QC Microbiology, Cell Therapy).
Responsible for supporting QC testing for in-process, final product, stability samples, and environmental/facility monitoring (including data review/verification). Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts.
Responsibilities
- Perform method transfer/verification/validation and routine testing of in-process, final product, and stability samples; conduct environmental/facilities monitoring and microbiological testing.
- Anticipate and perform routine troubleshooting and problem-solving with minimal guidance.
- Perform data verification and data review; review GMP documentation for general and complex methods.
- Perform document revision, project, CAPA, and deviation/investigation related tasks and/or continuous improvement efforts.
- Train and mentor others on QC test methods, processes, and procedures.
- Perform other tasks as assigned.
Qualifications
- Ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
- Demonstrated technical writing skills.
- High problem-solving ability; technically adept and logical.
- Effective communication with peers, management, and cross-functional partners.
- Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
- Advanced knowledge of LIMS and ELN and laboratory data analysis systems preferred.
- Bachelor’s degree or equivalent required (preferably in science); advanced degree preferred; Netherlands: MLO level 4 required.
- 4+ years of relevant microbiological testing or QC experience (preferably in a regulated environment).
- Demonstrated experience with microbiological techniques.
Compensation (Devens, MA, US)
- $43.84–$53.12 per hour.
Benefits (high level)
- Health coverage; wellbeing support; 401(k) and insurance/disability options.
- Paid time off, flexible time off/annual vacation varies by location/employee type; additional eligible leave and Global Shutdown.
Application instructions
- Apply for the role (requisition R1601149: Senior Specialist, QC Microbiology, Cell Therapy).