Manager, QC Microbiology, Cell Therapy

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Position Summary

Bristol Myers Squibb is seeking a Manager for QC Microbiology at the Cell Therapy Facility (CTF) in Devens, MA. This role will manage the daily operations of the QC Microbiology shift, responsible for environmental/utility monitoring and QC microbiology testing and data review for in-process and release testing of clinical and commercial cell therapy drug product.  The Manager of QC Microbiology shift will also be responsible for hiring, mentoring, and developing the QC Microbiology team to support business operations and employee career development. 

Support for QC and manufacturing operations requires shift coverage consisting of weekdays, weekends, holidays, and during adverse weather conditions.  This position directly leads the QC Microbiology shift scheduled for Sunday to Wednesday, 2PM to 12AM (midnight).

This role is stationed in Devens, MA and reports to the Senior Manager, QC Microbiology.

Key Responsibilities

• Supervise the QC Microbiology lab staff on shift and oversee the daily lab activities related to environmental/utility monitoring, in-process, and final release testing of cell therapy drug product.

• Develop and execute a work plan for the shift, ensuring safety, quality, and performance targets are achieved.

• Perform QC data review ensuring results are compliant with specifications and regulations.  Report abnormalities.

• Track, trend, and report key performance metrics.  Drive continuous improvement in the lab to increase productivity and efficiency.  May collaborate with other departments to identify and implement process improvements.

• Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures.

• Own and evaluate relevant change controls, investigations, deviations, CAPAs.

• Hire, mentor, and develop team members to support the business operations and employee career development.

• Oversee training of the team members.

• Communicate effectively with management regarding task completion, roadblocks, and needs.

• Responsible for cGMP compliance in all aspects of laboratory operations. Participate in site team supporting and managing regulatory inspections and findings.

• Perform other tasks as assigned.

Qualifications and Experience

• Experience with microbiology assays and associated equipment.

• Experience with laboratory LIMS, ELN, and ERP systems (e.g., SAP) preferred.

• Ability to work in a highly regulated environment and follow regulatory requirements and GMPs.

• Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environment.

• Advanced ability to work collaboratively in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.

• Excellent organizational and critical thinking skills.

• Advanced problem-solving ability/mentality, technically adept and logical.

• Advanced ability to communicate effectively with peers, department management and cross-functional peers.

• Proficient with Excel, Visio, PowerPoint, and other common software applications.

• Bachelor’s degree required, preferably in Microbiology or related science.

• 6+ years of relevant laboratory work experience, preferably in a regulated environment.

• 2+ years of management and people leader experience preferred.

• An equivalent combination of edu