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Quality & Regulatory
Job ID: 15255 Direct Hire MA
Our client is one of the top cell & gene therapy companies in the Cambridge/Boston area. This is with a mid-size company and they have a culture that can't be beat. Don't miss your chance to make a significant impact for patients afflicted with rare diseases and cancer.
The main function of this role is to lead analytical and bioanalytical validations and lifecycle management of QC methods to support release and stability testing of materials related to late stage clinical trials and eventual product commercialization.
The Hiring Manager has the flexibility to consider profiles ranging from senior individual contributors to Manager-level. Title and compensation will be commensurate with experience.
Ideally, the hiring manager is looking for two of the three following:
1. Experience with Method Qualification/Validation/Transfers.
2. qPCR/molecular biology based or cell-based assays. Understanding of cell culture methodology and technical aspects.
3. Experience in a cGMP setting, preferably in QC. Experience in GLP labs would be also be considered.
Responsibilities include but are not limited to;
• Designing analytical method qualifications and validations in accordance with cGMP/ICH/FDA/EU regulations that are phase-appropriate
• Manage test method transfer, assay validation and troubleshooting
• Author, review and approve test method validation protocols and reports
• Support monitoring of analytical method performance, including assessment of analytical method system suitability requirements
• Technical review of change control documentation and reports, deviations, OOS and other investigations
• Statistical analyses for evaluation of method performance and justifying product release specifications
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have a BS or MS and 5-10+ years of experience in a cGMP QC environment. Experience in cell therapy and gene therapy is welcome but not required.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.