Director/Senior Director, Chemistry, Manufacturing, and Controls (CMC)
Ribon Therapeutics is a biopharma company pioneering the development of small molecule first-in-class therapeutics targeting enzyme families that are activated under cellular stress conditions. We explore novel areas of disease biology and use our expertise in drug discovery to develop new and effective treatments for patients with high unmet need. Ribon offers a fast-paced, team-oriented work environment and a comprehensive benefits package, including health, dental, 401(k), paid vacation, and much more. Ribon is located in Cambridge, Massachusetts, which is easily accessible by car and public transportation.
- Lead all small molecule CMC-related activities including process chemistry, drug substance, drug product, analytical, and formulation from lead optimization phase through to commercialization.
- Manage drug substance and drug product CMOs and API supply chains to support clinical trial development.
- Set CMC strategy for project teams.
- Manage CMC timelines and budget .
- Author all CMC sections of regulatory filings including FDA, EMA and other national authorities to support the conduct of clinical trials.
- Act as subject matter expert for non-clinical CMC to both preclinical and development project teams. Interact with project teams to support CMC needs.
- Proactively identify knowledge gaps and risks, and work with teams and team leaders to develop mitigation plans.
- Facilitate internal CMC decision making processes and prepare regular updates for Senior Management .
Experience and Qualifications:
- 10 years of experience in the pharmaceutical/biotech industry with a MS or PhD degree in chemistry or other relevant discipline.
- Wide breadth of knowledge in all aspects of CMC including process chemistry, drug substance, drug product, analytical, and formulation.
- Excellent written and verbal communication skills with an ability to convey CMC strategies and results to a varied audience.
- Skilled in working on cross-functional teams to manage CMC timelines and program milestones.
- Experience with writing CMC sections for regulatory filings and knowledge of current regulations in US and EU.
- Meticulous, self-motivated, decisive, and independent.
- Excellent problem-solving skills and proven track record of delivering to aggressive timelines.
If you are interested in joining Ribon’s team, please email your resume to [email protected]