Scientist/Sr. Scientist, Process R&D-CMC
REVOLUTION Medicines, a clinical stage biotech company, dedicated to discovering and developing new drugs that translate frontier cancer targets through exceptional drug discovery delivering revolutionary medicines on behalf of cancer patients. Our innovative science draws inspiration from nature and evolution, which offer insights into cancer targets, disease mechanisms and therapeutic approaches. As a new member of the RevMed team, you will join other outstanding scientists who are helping lead our efforts in the discovery and development of new medicines for unmet needs in cancer.
Playing a critical role within CMC as the technical / project lead of Process R&D, the ideal candidate will be responsible for API process development, optimization, scale-up and manufacturing in support of pipeline compound development and clinical programs. Other responsibilities for the role include:
- Conduct API synthetic route evaluation, process development and manufacturing, technology transfer, and manufacturing processes.
- Source and develop raw materials, intermediates and regulatory starting materials.
- Work with project team(s) to identify API requirements, manage and optimize aggressive project timelines.
- Identify, select and manage CROs and CDMOs.
- Write, review and approve study protocols, manufacturing batch records, development and campaign reports.
- Write scientific reports to a broad scientific audience.
- Author and / or review the relevant CMC sections of regulatory filing documents.
- Partner with analytical development, pharmaceutical development and supply chain functions to design overall CMC strategy for programs.
- Interface with cross functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Project Management and Regulatory.
- Travel to CRO/CDMO for the oversight of development activities and manufacturing (up to approximately 20%).
Required Experience, Skills and Education:
- Preferably a PhD (minimum MSc. degree) in organic chemistry, chemical engineering or related discipline with ideally 5+ years of relevant experience in pharmaceutical process research and development.
- Hands-on experience in non-GMP and GMP API process development, scale-up and manufacturing.
- Knowledge and understanding of current ICH guidelines, GMP guidelines, and related industry practices.
- Working experience and knowledge of regulatory submission (IND, IMPD, and / or NDA).
- Proven ability to multi-task and handle multiple projects simultaneously with strong problem-solving skills and technically driven decision-making ability.
- Excellent organizational skills, detail oriented and thrives in a collaborative team setting.
- Effective communication skills (verbal, written and technical) and interpersonal skills.
- Team-oriented, progressive thinker who enjoys participating in an innovative, creative and high-energy work environment.