Head of Gene Therapy CMC
Job Opportunity at KOB Solutions, Inc.

Posted on Jun 28

http://www.kobsolutions.com/    412-851-9696

Location: New York, NY
Job Type: Full Time
Job ID: W4162713

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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