Title: QC Manager
Location: Lowell, MA
Reports to: Quality VP
Type of role: Hybrid
Salary: 120-180K
Our client is a leader in the cell and gene therapy space that is revolutionizing medicine and looking to add an accomplished and dynamic Quality Control leader to help with upcoming Laboratory expansion project.
This laboratory delivers Cell Biology, Biochemistry, and Safety assays in support of the production, release, and distribution of cell therapy products. The QC Manager will work in close collaboration with Global Engineering team and oversee Laboratory expansion project.
The QC Manager works in close cooperation with the Technical Services and Bio Analytical Services groups to ensure client methods are adequately qualified/validated and successfully transferred into the QC lab for use in support of the Operations.
- Manage laboratory equipment upkeep, calibration, and preventive maintenance and ensure proper documentation in logbooks and electronic management systems
- Ensure all method qualification and validation is current. Test procedures include bioassay methods, binding assays, flow cytometry, gene expression analysis, and microbial control assays (additional analytical platforms maybe implemented as per business needs)
- Keep apprised of compendial changes and ensure compliance with compendia for all test procedures
- Manage external vendors providing lab services and materials
- Minimum 8 years of experience working in biotechnology.
- Familiarity with Pharmaceutical Industry related to cGMP, regulatory standards and Biotech processes desirable.
- Minimum 5 years of experience in a leadership role with direct reports.
- Knowledge of LIMS, SAP and TrackWise systems a plus.
