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Head of Gene Therapy CMC
Job Opportunity at
KOB Solutions, Inc.
Posted on Jun 28
Head of Gene Therapy CMC
My client is expanding and looking to bring on a new person to lead CMC for Gene Therapy. The ideal candidate will take on the following tasks:
Plan, lead and communicate the CMC related strategies for gene therapy products, including selecting CROs and CMOs.
Actively manage CRO/CMOs for process optimization, scalable cGMP manufacture (both Drug Substance and Product) to supply a multi-product portfolio of pre-clinical and clinical gene therapy development programs.
Ensure phase-appropriate development and manufacturing (including assistance with analytical methods.)
Ensure CMOs supply high quality gene therapy products for clinical trials by overseeing batch record review, deviation assessment, batch disposition and supply chain oversight.
Direct CMO supply chain including critical raw materials, DNA plasmids, and cell and virus banks.
Apply Pharmaceutical QbD to gain required knowledge of the product portfolio and partner with Quality functions to ensure timely and appropriate batch disposition.
Collaborate with Preclinical and Clinical teams to ensure drug supply in a timely manner
Ensure proper preparation of cGMP batch records, technical reports, and Quality documents; Write and review documents for IND/regulatory section submissions.
Oversee Product and Process Development & GMP manufacturing of clinical supplies, including generation of cell and viral banks necessary to support process development and clinical manufacturing.
The ideal candidate will possess the following traits:
MS/PhD and 8+ years experience working in manufacturing in pharma/biotech.
Gene therapy experience required, experience in AAV gene therapy development highly preferred.
In-depth technical and regulatory understanding of GMP biologics manufacturing and supply chain, as well as applicable international regulations and standards in all phases of product development, including late-stage through commercialization.
Strong knowledge and demonstrated application of Pharmaceutical QbD princliples.
Excellent communication skills, with the ability to articulate a strategy and build support across the organization and external partners.
Experience with cGMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant FDA, ICH and EMA Regulations and Guidelines.
Proven leadership skills with the desire and ability to work in a fast-paced, start-up environment
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