Manager, Quality Control Sample Management in Devens, MA

Role Summary

Bristol Myers Squibb is seeking a Manager, QC Sample Management at the Cell Therapy Facility (CTF) in Devens, MA. This role will manage the daily operations of the QC Sample Management shift, responsible for the management of QC samples and materials in support of the QC laboratories. Responsibilities include mentoring, training and managing the QC Sample Management team, maintaining and tracking testing samples, retains, scheduling lab operations, supporting lot release, creating and continuously improving processes, reviewing and approving documents, and overseeing sample tracking, delivery, and destruction.

Responsibilities

• Provide supervision of QC Sample Management shift and oversee the daily Sample Management activities related to in-process, final release and stability testing of cell therapy drug product.
• Develop and manage a daily work plan for QC associates. Report out quality and operational metrics.
• Responsible for management of QC samples and materials including chain of custody, label, receipt, storage, transfer, and disposal according to GMP requirements and approved procedures. Facilitate cold chain transfers of samples, as required.
• Hire, mentor and develop the team members to support the business operations and employee career development.
• Oversee the training of the team members.
• Review and approve procedures for Sample Management activities.
• Collaborate with other departments to identify and implement process improvements.
• Own and evaluate relevant change controls, investigations, deviations, CAPAs.
• Apply critical thinking skills when working on new procedures or process improvements.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Perform other tasks as assigned.

Knowledge, Skills, Abilities

• Experience with cold chain sample storage and transfer in a GMP regulated environment.
• Familiar with Excel, Visio, Power Point, and other software systems.
• Experience with laboratory LIMS 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 assignment while meeting timelines in a GMP environment.
• Advanced ability to work in a collaborative team environment and train others.
• Advanced ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Excellent organizational and critical thinking skills.
• Advanced ability to communicate effectively with peers, department management and cross-functional peers.

Basic Requirements

• Bachelor's degree required, preferably in Chemistry, Microbiology or related science.
• 6+ years of relevant work experience, preferable in a regulated environment.
• 2+ years of management and people leader experience.
• An equivalent combination of education and experience may substitute.
• The incumbent will be working around biohazardous materials.
• The incumbent may be exposed to fluctuating and/or extreme temperatures on occasion.