Director, Process Development and CMC (Gene Therapy)

Location
South San Francisco, California
Posted
Jun 11, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

Tenaya Therapeutics was founded in Oct 2016 to address heart failure by targeting the fundamental cellular pathologies present in diseased cardiac muscle. Tenaya is building a rigorous, motivated, and collaborative team dedicated to developing cutting-edge research into therapies for heart failure patients.

We are looking for an entrepreneurial Director of CMC to join our team and contribute to bringing our lead gene therapy program to the clinic. In addition to gene therapy, experience in small molecule and biologic development would be relevant across our discovery portfolio.

Responsibilities

  • The Director of CMC will effectively plan, lead, and communicate key CMC strategies for a gene therapy product.
  • Recruit and manage build out of internal CMC team; select and manage Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) for process optimization, scalable cGMP manufacture, and supply of drug product.
  • Develop stage-appropriate analytical methods, upstream and downstream processes, and formulations towards delivering GMP clinical trial material.
  • Collaborate cross-functionally with Preclinical and Clinical teams to ensure drug supply in a timely manner (managing timelines and supply chain), and work with Finance team to manage budget.
  • Ensure proper preparation of cGMP batch records, technical reports, and Quality documents; Write and review documents for IND/regulatory section submissions.

Desired Skills and Background

  • A PhD or MS with 8+ years of relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment, with a preference for strong molecular biology experience. The ideal candidate will have clinical stage CMC experience with AAV and/or lentivirus.
  • Exceptional management skills and commitment to mentorship to foster collaboration, promote internal growth, and inspire high performing teams.
  • High bandwidth for implementing technical, strategic, and operational plans with a proven track record in identifying and resolving critical issues.
  • Outstanding communication skills, with the ability to articulate a strategy and build support across the organization and external partners (CROs/CMOs).
  • Experience with cGMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations.

For immediate consideration, please share your CV, complete with publication record, through our careers site.  Tenaya is proud to be an equal opportunity workplace.