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.

Job Responsibilities:

• 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 g.watson@proclinical.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.

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