Associate Director, Network Materials QC

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.

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This leadership role will lead a global QC team responsible for technical program and method oversight for Raw Materials (RMs) and QC Critical Reagents (QCCRs) within the Network Cell Therapy commercial and late-stage development. The scope of this role includes media, buffers, reagents used in drug product manufacturing as well as materials used in QC requiring testing prior to use (QCCRs) and custom QC critical reagent suppliers. This role is above site (Network QC) and supports all Cell Therapy commercial manufacturing sites.

Shift Available:

• Monday - Friday Onsite Day Shift

Responsibilities:

• Leadership of the team responsible for management of the Network Material QC program inclusive of raw materials and QC critical reagent testing methods, technical QC support for these materials as well as strategic direction of the Material QC program shared across the Cell Therapy network of commercial sites. Further, lead the functional QC support for the suppliers, contract testing labs, troubleshooting/ investigations, material qualifications, onboarding and changes associated with Network Materials.

• Provide oversite of the materials QC program for the network of sites.

• Set strategic direction for the implementation of risk minimizing sourcing and testing strategies for QC critical reagents used in Drug product and vector testing.

• Set strategic direction for the implementation of risk minimizing testing strategies for raw materials used in drug product and vector manufacturing.

• Oversee implementation, review and approval of documents to drive and support the material Network QC program including incoming materials specifications, Justification of Specifications and material qualifications.

• Coordinate and work collaboratively with cross-functional teams including MS&T, AS&T, supply chain, Procurement and across multiple commercial manufacturing sites to drive the materials QC program.

• Measure and maintain KPIs and Quality metrics.

• Provide expert level industry bioanalytical knowledge and in-depth understanding of bioanalytical techniques and quality control strategies.

• Lead the handling complex issues, provide troubleshooting, investigations and Inspection support.

• Responsible for management of group projects; designs and execution of experiments, result analysis, technical reports and continuous improvement projects.

• Perform analyses and determine appropriate actions with regards to lab investigations, deviations, CAPAs, and continuous improvement to ensure continued compliance with all cGMP requirements.

• Anticipate and troubleshoot issues with regards to processes, procedures, documentation, instrumentation and electronic systems.

• Lead and develop best practices within the team including fostering lean principles.

• Mentor and coach group members for ongoing growth with technical expertise and skills, soft skills and leadership.

• Develop and sustain self-directed work teams to support team ownership for effectively and efficiently completing activities.

• Participate in hiring processes internal and external to the group.

• Determine group training curricula and oversee development of training content.

• Provide feedback to direct reports through regular coaching sessions.

• Utilize company-guided performance management tools and processes.

• Ensure group members have and use appropriate engineering controls, safety procedures and PPE. 

• Encourage a strong culture of team and individual safety awareness and accountability.

Knowledge & Skills:

• Self-directed with a high d