QC Analytical Manager, Molecular, Cell Therapy in Devens, MA

Role Summary

Manager, QC Analytical, Molecular at the Cell Therapy Facility (CTF) in Devens, MA. Manages daily QC Analytical shift operations, bioanalytical testing and data review for in-process, release, and stability testing of clinical and commercial cell therapy drug product. Responsible for hiring, mentoring and developing the QC Analytical team to support operations and employee career development.

Responsibilities

• Supervise the QC Analytical lab staff on shift and oversee daily lab activities related to in-process, final release, and stability 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. 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.

Knowledge, Skills, Abilities

• Experience with various bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry) 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.
• The incumbent will be working around biohazardous materials.

Qualifications

• Bachelor's degree required, preferably in Chemistry, Microbiology or related science.
• 6+ years of relevant laboratory work experience, preferably in a regulated environment.
• 2+ years of management and people leader experience.
• An equivalent combination of education and experience may substitute.

Education

• Bachelor's degree in a related science field (Chemistry, Microbiology or related) required.