CMC Director, Small Molecule
Oakland-Fremont-Pleasanton Metro Area, CA
We are a VC-funded, SF-based (East Bay) pharmaceutical company. Based on our positive phase 2 trial results, we are poised to enter phase 3 clinical trials for treating neurodegenerative disorders, such as Alzheimer's Disease.
We are looking for a CMC Director to oversee the chemistry, manufacturing, and controls of a compound for late phase clinical trials. This position will be located at our Walnut Creek, CA office.
This position provides a phenomenal opportunity for a talented individual who seeks exposure and participation across all dimensions of a very well-positioned biotechnology company's growth.
- Evaluate and select API and drug product CMOs.
- Be the primary liaison with CMOs. Manage and monitor CMOs for tech transfer and development of new and existing API and drug product. Scale-up, manufacturing, and packaging for phase III clinical trial products
- CMO Quality (QA) and Regulatory assurance (RA)
- Support CMOs during the development and validation phases of projects
- Preparation and submission of CMC sections of IND and NDA, including responses to questions from FDA.
- Maintain awareness and act as expert on regulatory CMC requirements.
- Advanced degree in Chemistry, Chemical Engineering, or Biochemistry
- B.S. ( >15 years) or M.S. or Ph.D. ( >8 years) industry experience in API and drug product synthesis, scale-up, manufacturing, packaging, technology transfer registration and QA/RA.
- Specific experience and expertise with small molecules and drug tablet formulation is required
- Knowledge of CMC, product development, product quality, manufacturing, bioanalytical assays and assay development, and qualification/validation assays is essential.
- Experience in outsourcing, vendor management, establishing and managing consultants and CMOs for timely, clear, and accurate deliverables.
- Experience in preparing regulatory submissions, including INDs and NDAs
- Deep understanding of QA, RA, regulatory and clinical functions to guide CMC and CMC-related clinical activities.
- Strong interpersonal and communication skills and the ability to work effectively in a fast-paced environment with a tight-knit internal team and external providers.
- Walnut Creek, CA
- CMC: 8 years