Senior Specialist, QC Analytical, Cell Therapy
Bristol Myers Squibb
3 months ago
On-site
Devens, MA
Operations
Position Summary:
Responsible for supporting QC testing for in-process, final product, and stability samples, including data review/verification. Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts.
Duties/Responsibilities:
- Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
- Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
- Perform data verification, data review, and review of 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:
Specific Knowledge, Skills, Abilities:
- Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
- Demonstrated technical writing skills.
- High problem-solving ability; technically adept and logical.
- Ability to communicate effectively with peers, department management, and cross-functional peers.
- 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.
Education/Experience:
- Bachelor’s degree or equivalent required (preferably in science).
- 4+ years of relevant analytical testing or QC experience (preferably in a regulated environment).
- Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, aseptic technique).
Compensation Overview (Devens, MA):
- $43.84–$53.12 per hour (starting range). Additional incentive cash/stock may be available (based on eligibility).
Responsible for supporting QC testing for in-process, final product, and stability samples, including data review/verification. Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts.
Duties/Responsibilities:
- Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
- Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
- Perform data verification, data review, and review of 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:
Specific Knowledge, Skills, Abilities:
- Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
- Demonstrated technical writing skills.
- High problem-solving ability; technically adept and logical.
- Ability to communicate effectively with peers, department management, and cross-functional peers.
- 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.
Education/Experience:
- Bachelor’s degree or equivalent required (preferably in science).
- 4+ years of relevant analytical testing or QC experience (preferably in a regulated environment).
- Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, aseptic technique).
Compensation Overview (Devens, MA):
- $43.84–$53.12 per hour (starting range). Additional incentive cash/stock may be available (based on eligibility).