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Job type: Permanent

Discipline: Analytical Chemistry, Biological Sciences, Genetics & Genomics

Location: United States

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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