Senior Manager, QC Analytical

Company: Bristol-Myers Squibb
Location: Summit
Posted on: November 6, 2024

Job Description:

Senior Manager, QC AnalyticalWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.The Senior Manager, QC Analytical Testing is responsible for all operational aspects of the QC Analytical Testing department at the Cell Therapy Operations (CTO) manufacturing facility during clinical and commercial phases. This department is responsible for Flow Cytometry and Molecular Biology based testing of in-process samples, final drug product testing, stability testing, validation and requalification support, critical reagent testing and qualification, training, deviation, CAPA, and change controls and other critical support as needed. The Manager, QC Analytical is responsible for continuously maintaining the GMP status of the QC Laboratory, applying and ensuring staff complies to EHS rules and safe work practices per applicable procedures, while still performing hands-on testing as needed.Shift Available:Wednesday - Saturday, Onsite Day Shift, 8 a.m. - 6 p.m.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.Knowledge & Skills:
  • 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:
    • Bachelors' 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.
    • People leadership: A minimum of 2 years' experience.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.
      • The incumbent (or designee) will be expected to be on call to support manufacturing issues involving sampling and/or test excursions or questions during shift operations.
      • Occasional travel may be required.
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Keywords: Bristol-Myers Squibb, East Brunswick , Senior Manager, QC Analytical, Executive , Summit, New Jersey