Scientist, QC Microbiology, Cell Therapy
About The Position
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 Subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples. Perform data review/verification, complex troubleshooting, and method training. Own project, document revisions, deviations/investigations/CAPA, and continuous improvement efforts
Requirements
- Bachelor’s degree or equivalent required, preferably in science. Advanced degree preferred.
- 6+ 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.
- 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.
- Advanced ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
- Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.
- Strong mentoring, coaching, influencing, negotiating and personnel interaction skills.
Responsibilities
- Subject matter expert supporting method transfer/verification/ validation and routine testing of in-process, final product, and stability samples.
- Perform review of testing data (e.g., data packets, final lot file, COA review).
- Anticipate and perform complex troubleshooting and problem solving independently.
- Perform data verification, data review and review of GMP documentation for multiple methods (general and complex) and/or products.
- Own project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
- May represent the department in regulatory inspections (internal and external audits).
- Train and mentor others on multiple QC test methods, processes and procedures.
- Cross trained on multiple complex microbiology methods and/or multiple products.
- Author and review/ revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans as appropriate.
- Perform other tasks as assigned.
Benefits
- wellbeing support
- retirement and financial protection benefits
- insurance offerings (medical, dental, vision, life and disability)
- Flexible Time Off (FTO)
- 11 paid company holidays
- 160 hours of paid vacation annually for new hires
- 3 optional holidays
- paid sick leave
- up to two paid volunteer days per year
- summer hours flexibility
- leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- annual Global Shutdown between Christmas Day and New Year's Day
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What This Job Offers
Job Type
Full-time
Career Level
Senior
