Senior Specialist, QC Analytical, Cell Therapy

Bristol Myers SquibbSummit, NJ
$41 - $50Onsite

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 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. Shift: Sunday to Wednesday 1:30pm to 11:30pm.

Requirements

  • 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.
  • Bachelor's degree or equivalent required, preferably in science. Netherlands: Bachelor's degree / HLO in (bioanalytical) science required.
  • 4+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
  • Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique).

Nice To Haves

  • Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred

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.

Benefits

  • wellbeing support
  • retirement and financial protection benefits
  • insurance offerings (medical, dental, vision, life and disability)
  • Flexible Time Off (FTO)
  • 11 paid company holidays each year
  • 160 hours of paid vacation annually for new hires
  • 11 paid company holidays
  • 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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