Manager, QC Analytical Testing

Working with Us
Challenging. 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. Read more: careers.bms.com/working-with-us.

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 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:

• Manages all activities related to the QC Analytical Testing department including:

• GMP release of in-process and drug product testing results.

• Documentation of GMP release activities.

• Ensures the laboratory is inspection ready at all times.

• Perform data review of experiments, governing procedures, protocols and release data. 

• Participate in complex projects and continuous improvement efforts. 

• Perform and document training effectively.

• Method development and validation.

• Manages and develops direct reports including:

• Management and scheduling of personnel within the department to meet manufacturing and laboratory schedules and needs.

• Ensuring employees are properly trained and qualified to perform their assigned tasks, providing performance evaluations, and supporting career development of direct reports.

​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

• 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