Senior Specialist QC Microbiology Cell Therapy
About the role
At Bristol Myers Squibb, our employees often ask, "Who are you working for?" - a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Position Summary
Responsible for supporting QC testing for in-process, final product, stability samples and for supporting environmental and facility monitoring, including data review/verification. Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts.
Shift: Sun-Wed 1pm-1130pm
Duties/Responsibilities
- Perform method transfer/ verification/ validation, routine testing of in process, final product, and stability samples. Perform environmental/facilities monitoring and microbiological testing.
- 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/mentality, technically adept and logical.
- Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
- Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
- Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.
Education/Experience/ Licenses/Certifications:
- 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 or equivalent combination of education and experience, preferably in a regulated environment.
- Demonstrated experience with microbiological techniques
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
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