Manager, Quality Control Sample Management in Devens, MA

Role Summary

Manager, QC Sample Management at the Cell Therapy Facility (CTF) in Devens, MA. Oversees the daily operations of the QC Sample Management shift, including mentoring, training, and managing the team; maintaining and tracking testing samples, retains, scheduling lab operations, supporting lot release, creating and improving processes, reviewing documents, and supervising sample tracking, delivery, and destruction.

Responsibilities

• Provide supervision of QC Sample Management shift and oversee 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 quality and operational metrics.
• Manage QC samples and materials (chain of custody, label, receipt, storage, transfer, disposal) per GMP requirements; facilitate cold chain transfers as required.
• Hire, mentor and develop team members to support operations and career development.
• Oversee the training of team members.
• Review and approve procedures for Sample Management activities.
• Collaborate with other departments to identify and implement process improvements.
• Own and evaluate change controls, investigations, deviations, and CAPAs.
• Apply critical thinking when developing new procedures or process improvements.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Perform other tasks as assigned.

Qualifications

• Required: Bachelor’s degree in Chemistry, Microbiology, or related science.
• Required: 6+ years of relevant work experience, preferably in a regulated environment.
• Required: 2+ years of management and people leader experience.
• Equivalent combination of education and experience may substitute.
• Note: Exposure to biohazardous materials; potential for fluctuating/extreme temperatures.

Knowledge, Skills, Abilities

• Experience with cold chain sample storage and transfer in a GMP regulated environment.
• Proficiency with Excel, Visio, PowerPoint; familiarity with software systems.
• Experience with 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 and manage multiple assignments while meeting timelines in a GMP environment.
• Strong collaboration skills and ability to train others; capable of working independently in a fast-paced environment.
• Excellent organizational and critical thinking skills; strong communication with peers and management.

Education

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