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CMC Strategy, Manager

Company: Instil Bio
Location: Thousand Oaks
Posted on: May 3, 2021

Job Description:

Instil Bio is looking for a Manager of CMC Strategy, Process Development in the Greater Los Angeles or Thousand Oaks area.

This role will be responsible for supporting activities related to development of CMC strategy and ensuring appropriate technical content for regulatory submissions. This role will work closely with multiple groups such as process development, analytical sciences, manufacturing, quality, tech transfer and regulatory affairs to ensure successful completion of Tech Ops deliverables required for successful IND and BLA submissions.

Responsibilities (include but are not limited to):

  • Support the defining of CMC Strategy and Tech Ops deliverables required for clinical and commercial license applications (e.g. INDs, BLAs)
  • Author CMC submission sections and RTQs
  • Work with crossfunctional teams and subject matter experts to generate the required technical content for regulatory filings
  • Timeline creation, maintenance and basic project management
  • Perform other related duties and assignments as required


  • Minimum of bachelors degree in appropriate scientific, engineering, life sciences discipline e.g. chemical/biochemical engineering, biomedical engineering, microbiology, biochemistry etc.
  • 5+ years of industry experience in Biotech with ideally 2+ years being in cell therapy CMC support, process development, tech transfer, MSAT or other appropriate Tech Ops/CMC or Regulatory Affairs related function
  • Experience leading crossfunctional technical teams
  • Experience supporting either regulatory agency submissions, inspections or responses to questions (RTQs) (or equivalent experience in e.g. process development and process characterization/commercialization, analytical development, MSAT or tech transfer)
  • Technical writing experience
  • Presentation skills
  • Basic project management skills

Keywords: Instil Bio, Thousand Oaks , CMC Strategy, Manager, Other , Thousand Oaks, California

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