ImmunoGen Inc. is seeking a Quality Control Manager that will provide a functional oversight on QC analytical and biological methods transfers, optimization and maintenance. Provide matrix management within QC for assay transfer and qualifications. This includes assays transferred into QC from development group, partners and CMOs/CTLs or from QC to external labs. Serve as the point person for transfers and qualifications, ensuring that all data is place and documentation is complete but work with the other QC managers for resourcing the activities.
BS degree in chemistry or biology, advanced degree preferred. Minimum of 7 years relevant experience including experience in a leadership role as an effective people manager. Strong expertise in analytical and bioanalytical testing of biopharmaceutical products. Experience in assay development, transfer and qualification and the interpretation and implementation of ICH assay validaiton guidelines. Strong statistical analyses skills required. Experience with LIMS preferred. Strong organizational skills and detail orientation. Solid written and oral communication skills. Position may require some travel, up to approximately 15%.
- Serve as Immunogen SME on assay transfer
- Manage staff, provide guidance and career development to direct reports
- Develop individual goals and group goals
- Develop and manage analytical\bioassays lifecycle
- Design and manage assay performance monitoring program
- Collaborate with analytical development groups, partner, CMOs & CTLs to ensure robust assay development, transfer and validations
- Ensure appropriate completion of documentation related to assay evaluation, transfer, valdation and implementation
- Track quality of analytical methods and work with team to maintain and improve methods where appropriate
- Assist in writing / review of regulatory documents, reports
- Represent QC at cross-functional meetings
- Support other QC functions as needed
ImmunoGen, Inc. - 18 months ago