Rapport Therapeutics, a well funded Third Rock start up with sites in Boston and San Diego is seeking a talented VP of CMC to serve as an internal expert and build this function in our company. Reporting to the CDO, the incumbent will be required to work flexibly across a number of small molecule drug development programs with responsibilities for both drug substance synthesis & scale-up and drug product development and manufacturing campaigns. All activities are expected to be outsourced.
RESPONSIBILITIES:
As the technical and scientific expert,
- Lead and manage multiple and concurrent drug substance projects, with responsibilities including:
- API process development, optimization and validation
- Salt form selection
- cGMP API manufacturing campaigns
- Scale-ups and technology transfer
- Lead and manage formulation development, which may entail one or more of
- oral and injectable product development (e.g. tablets, capsules, IV and IM etc.)
- immediate and sustained release products (e.g. once-daily, once-monthly etc)
- fixed dose combination
- Oversee manufacture of cGMP drug product manufacture, labeling & packaging, including review and approval of batch records
- Oversee analytical method development, review results, QC and approval
- Evaluate, recommend and select vendors for drug substance manufacture, formulation development and drug product manufacture
- Visit vendors to oversee manufacturing campaigns and participate in audits
- Identify CMC-related risks and facilitate mitigation planning
- Contribute to the drafting of the CMC sections of regulatory submissions (e.g., INDs, CTAs, NDAs) and respond to any queries from regulatory authorities
- Work with QA to ensure compliance in all of the outsourced activities
- Set up CMC team meetings, cross-functional team meetings to ensure timely delivery of clinical supplies and documentation
QUALIFICATIONS:
- PhD in organic chemistry, pharmaceutics, chemical engineering or related field
- 10+ years experience in the pharmaceutical industry, directly related to above mentioned CMC activities, with sufficient exposure to both DS and DP manufacturing and troubleshooting.
- Experience working, collaborating with, and managing CDMOs.
- Good knowledge of formulation options and troubleshooting
- Good knowledge and understanding of cGMP of small molecule DS/DP and of the US, Canadian and EU regulatory environments; previous experience with IND and CTA CMC submissions preferred.
- Excellent written and oral communication skills, including experience in technical writing in support of regulatory submissions.
- Excellent attention to detail and commitment to providing accurate, high quality work.
- Good organizational skills and the ability to manage multiple competing priorities.
- Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.