Senior Manager, QC Analytical Testing

4 weeks ago

Summit, New Jersey, United States Bristol-Myers Squibb Full time
Transforming Patients' Lives through Science

Bristol-Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. We are seeking a highly skilled and experienced Senior Manager, QC Analytical Testing to join our team.

About the Role

The Senior Manager, QC Analytical Testing will be responsible for leading the QC Analytical Testing department at our Cell Therapy Operations (CTO) manufacturing facility. This role will oversee all operational aspects of the department, ensuring effective, timely, and efficient operations and compliance with cGMP requirements.

Key Responsibilities
  • Create a positive and collaborative team environment and ensure that Bristol Myers Squibb standards are met.
  • Oversee QC analytical team/s to ensure effective, timely, and efficient operations and compliance with cGMP requirements.
  • Lead by example to foster a culture of teamwork and operational excellence and embed BMS values within operational activities.
  • Develop and report KPIs for QC Lab Operations performance.
  • Maintain high team performance and drive continuous improvement initiatives using operational excellence tools.
  • Hire, mentor, and develop team members to support business operations.
  • Provide developmental feedback, coaching, and create a collaborative environment to enhance team performance and integration across site departments.
  • Approve investigations and creation of meaningful CAPA for improved lab performance.
  • Collaborate with managers across the QC network to harmonize best practices.
  • Represent department in regulatory inspections (internal and external audits). May author responses to inspection requests.
  • Create metrics to monitor assay performance and help identify risk areas.
  • Perform review of experiments, governing procedures, protocols, and release data.
  • Participate in complex projects and continuous improvement efforts.
Requirements
  • Extensive experience with flow cytometry and cell imaging, including flow-related technologies related to analysis.
  • Extensive experience with various molecular biology analytical techniques, including but not limited to ELISA, qPCR, and scientific knowledge in the characterization and transfer of pharmaceutical products.
  • Knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products.
  • Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences, including presenting to site leadership.
  • Ability to collaborate cross-functionally to drive operational and quality excellence.
  • Advanced organizational and time management skills.
  • Demonstrated critical reasoning, problem-solving, troubleshooting, investigation, and decision-making skills with only general guidance.
  • Advanced teamwork and facilitation skills.
  • Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills.
  • Requires strategic thinking and ability to work independently.
  • Advanced knowledge of Quality Systems, including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments.
  • Ability to interpret and author general, technical, and complex business documents.
  • Advanced knowledge and implementation of data integrity principles.
  • Ability to represent the department in regulatory inspections.
  • Communicate effectively with management regarding task completion, roadblocks, and needs.
  • Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility, and tolerance.
  • Proficiency in MS Office applications.
Basic Requirements
  • Bachelor's degree required, preferably in Biology or related science. Advanced degree preferred. An equivalent combination of higher education and experience may be considered.
  • Minimum of 5 years of combined work experience in QC Analytical testing within a manufacturing GMP facility.
  • Proficiency in flow cytometry, ELISA, PCR, and cell handling/cell culture.
  • Strong ability to speak to and explain all the above techniques.
  • A minimum of 2 years' experience in people leadership.
Working Conditions

The incumbent will be required to work in office and laboratory environments. The incumbent may be required to gown for entry into the Aseptic Core and other supporting areas on an as-needed basis. Occasional travel may be required.

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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