San Diego, Boston, Full Time

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.


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


  • 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.
Job Type: Full Time
Job Location: West Coast East Coast
Job City: San Diego Boston

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