C4 Therapeutics is looking for a highly motivated, creative, team player that aspires to contribute to the process development of small molecule therapeutics, from pre-clinical stage optimization to the clinical stage production.
- Support process research for projects in lead-optimization, IND-enabling, and phase 1 development.
- Scale-up discovery routes for key molecules and as needed, route scout and scale-up key intermediates to 1) enable development candidate short-list molecule identification, 2) identify and understand opportunities for process control points.
- Develop and optimize scalable processes for API manufacturing. Identify process improvements, implement in the lab and demonstrate on the scale.
- Lead internal and external process research activities, prepare timely documentation, and supervise external FTEs and/or CMOs to deliver API to support pre-clinical TOX and clinical studies.
- Identify impurities generated during API manufacturing and stability tests. Develop synthetic routes to prepare these impurities in gram scale.
- Provide support and technology transfer to CMOs, and oversee manufacturing at CMOs.
- Support documentation for IND filing.
- Provide research proposals, prepare internal research reports and technical presentations.
- Ph.D. in Organic Chemistry with 5+ years of relevant industrial experience in process chemistry.
- Detailed knowledge in process and analytical chemistry, purification, crystallization, technology transfer, scale-up and manufacture, regulatory affairs, and cGMP practice.
- Experience in process chemistry R&D, scale-up synthesis, and support of API production under cGMP for clinical trials.
- Ability to organize and analyze complex data for development reports and IND filing.
- Excellent written and oral communication skills, demonstrated ability to work effectively in a team environment.
- Travel associated with technology transfer and production oversight of CMOs/CROs is required.