Job posting: associate director, CMC/drug substance, Olema Oncology, San Francisco, CA

Via LinkedIn, this position: 

As the Associate Director, CMC Drug Substance Development and Manufacturing reporting to the Senior Director of CMC Drug Substance you will support drug substance process development and cGMP manufacturing activities at external contract manufacturing and development organizations (CDMOs). We are looking for an experienced process chemist with a track record of successful oversight of manufacturing small molecule drug substances under cGMP. In addition to supporting process development activities and managing manufacturing campaigns, including reviews of master and executed batch records, this individual will contribute to the preparation and review of technical development reports and authoring of the CMC sections of regulatory submissions including INDs, IMPDs, NDAs, etc. 

This role is based out of our San Francisco or Boston office and will require up to 10% travel. 

Your work will primarily encompass: 

• Provide technical guidance and lead drug substance process development, manufacturing and CDMO management  
• Lead technical meetings with CDMOs and provide status updates to internal teams 
• Represent drug substance function on cross-functional CMC and project teams, providing technical and strategic input 

Knowledge and Experience: 

• M.Sc. or Ph.D. in Organic Chemistry, or related discipline with 8+ years of experience in a CMC development organization 
• Expertise in small molecule process development and GMP manufacturing, preferably across all phases of development (pre-IND to commercial manufacturing) 

Full ad here. Best wishes to those interested.