Job Description: Our biotech client needs a Regulatory CMC Consultant. Job is Part-time. Some CAR-T experience is wanted for this. Some other projects are gene therapy which are on the backburner but possible in the future. Mostly Module 3 and 2.3, one product is an active IND and a second filing coming soon. Lifecycle management. Must have IND experience. BLA experience a plus but not required. Prior biologics experience if not CAR-T experience. Experience around the 10 year mark. 3-5 years of CAR-T experience wanted.
Skills: regulatory, CMC, CAR-T
Location: Remote, possibly a visit once to meet team
Remote in MA: Regulatory CMC Consultant (233298)