Associate Director / Director, CMC

Cedilla Therapeutics is a close-knit, driven, and patient-focused team of drug discovery and oncology experts bringing a new dimension to precision oncology. We have discovered new ways to selectively inhibit oncogenic drivers with small molecules that conditionally modulate proteins in their functional state. Our conditional inhibitors are unlocking critical and elusive cancer targets including TEAD and CDK2.  This is an exciting opportunity to join a fast-paced start-up environment, and candidates who are keen experimentalists, enthusiastic, creative, and have a passion for drug discovery should apply.

We are looking for an experienced CMC Head to chaperone small molecule candidates from late LeadOp / candidate selection through to Phase I / II clinical trials.  The successful candidate will have managed small molecule compound formulation and manufacture via CROs and CMOs as well as have experience with authoring the CMC sections required for IND submissions.

We view you as an important team member whose contributions will be critical to our success.  Those contributions will include:

  • Providing CMC leadership and contributing to overall strategies as a core member of Cedilla development teams, to ensure that drug candidates are viable molecules for development.
  • Responsibility for the manufacture, labeling, and supply of both drug substance and drug product for molecules entering development using contract research and manufacturing organizations. 
  • Evaluating and developing scalable small molecule synthesis routes that allow fit-for-purpose scale-up of materials under both non-GMP and GMP conditions.
  • Determining the formulation feasibility of drug candidates, in conjunction with colleagues in DMPK and pharmacology.
  • Assuring that appropriate GMP regulations are followed internally and by CROs/CMOs, and that appropriate CMC regulatory/QA documents are prepared in a timely manner.

Requirements and Qualifications:

  • Deep knowledge of CMC regulatory guidelines and experience creating the CMC section of INDs and other regulatory filings¬†is a must.
  • Ph.D. or equivalent in chemistry or pharmaceutical sciences, with at least 10 years of relevant industry experience.
  • Expertise in formulations will be favorably considered.
  • Experience in selecting and managing CROs / CMOs to achieve high quality results under tight timelines, while mitigating risks.
  • Strong abilities to assess risk and use judgment to make recommendations to project teams and senior management.

To apply, please submit your resume to