Instil Bio is looking for a Manager/Senior Manager of CMC Strategy, Process Development in the Greater Los Angeles or Thousand Oaks area.
Your role will be responsible for supporting activities related to development and execution of CMC strategy and ensuring appropriate technical content for regulatory submissions. This role will work closely with process design, analytical sciences, manufacturing, quality, tech transfer and regulatory affairs groups to ensure successful completion of Tech Ops deliverables required for successful IND and BLA submissions. Additionally you will provide support for planning workshops, CMC authoring, RTQs, project co-ordination and, based on experience, may provide cross-functional support for process development activities such as design, tech transfer, process analysis and monitoring, MSAT, technical writing, risk assessment and validation/comparability.
Responsibilities:
- Supporting CMC Strategy and Tech Ops deliverables required for IND and BLA
- CMC Authoring and technical writing
- Co-ordination with cross-functional teams and subject matter experts
- Timeline creation, maintenance and basic project management
- Support responses to Regulatory Agency questions, (RTQs)
Requirements:
- Minimum of bachelor’s degree in appropriate scientific, engineering, life sciences discipline e.g. chemical/biochemical engineering, biomedical engineering, microbiology, biochemistry etc
- 6-10 years of industry experience in Biotech with 3+ years being in cell therapy process development, tech transfer, MSAT or other appropriate tech ops/CMC related function.
- Experience leading cross-functional technical teams
- Some experience supporting either regulatory agency submissions, inspections or responses to questions (RTQs) (or equivalent late stage process development and process characterization/commercialization, MSAT or tech transfer experience).
- Technical writing experience
- Presentation skills
- Basic project management skills