Director/Senior Director CMC Analytical Validation
Proclinical is currently recruiting for a Director/Senior Director of CMC Analytical Validation with a leading gene-therapy company located in Boston, MA. As the of CMC Analytical Validation Director/Senior Director, you will be responsible for method transfers; method improvement; method remediation and method validation/verification and/or troubleshooting for late stage clinical products within the Quality Control laboratories.
- Monitors and manages the life cycle of assigned analytical methods supporting late stage clinical products. This includes, but not limited to, oversight of stability programs, reference standards and preBLA commitments.
- Designs and oversees experiments evaluating analytical methods associated with commercial products for feasibility, method improvement, remediation, and/or troubleshooting.
- Leads continuous cGMP analytical improvement projects. This includes, but may not be limited to, constant state of validation, improvement of methods and sustaining compliance with global requirements.
- Troubleshoots method and/or equipment issues to the root cause. Assesses issues with resource management and failure investigation review
- Resolves non-routine laboratory issues and problems expeditiously.
- Provides scientific review and approval of protocols, reports, study design and standard operating procedures.
- Acts as project lead for assigned programs
Skills and Requirements:
- PhD in molecular biology, virology, biochemistry or related field and a minimum of 7 years of progressively responsible experience in cell and gene therapy Quality Control, MS&T or AS&T roles OR a Master's degree in these same disciplines and a minimum of 9 years of relevant and progressively responsible experience in these same areas.
- Comprehensive experience with the analytical methods used for cell and gene therapy in-process testing, release testing and characterization, with an emphasis on potency assays.
- Expert level knowledge of CMC analytical and regulatory requirements.
- Significant and applied experience in laboratory operations, including development and adherence to quality metric programs
- Experience in departmental budgeting, capex procurement, IQ/OQ, safety, and status reporting to Senior Management.
- Expert level knowledge of cGMP requirements as they pertain to analytical development and quality control testing.
- Functional knowledge of mammalian cell culture.
- Expert knowledge of cell-based assays, flow cytometry, qPCR, ddPCR, ELISA and molecular biology techniques.
- Prior experience the commercial release testing within CROs/CMOs.
- Team oriented and able to manage multiple projects across various development stages.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
If you are having difficulty in applying or if you have any questions, please contact Matthew Tong at (+1) 646-878-6308 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.