Director, CMC API Process Development and Manufacturing

We are currently seeking a highly motivated, creative CMC drug substance professional to join our CMC team in San Diego.

Role responsibilities

• Evaluate available candidate synthetic routes and develop stage appropriate route modification and process optimization strategies.
• Select external CRO/CDMO partners based on project needs and the external parties’ technical capabilities, quality system, and track records. 
• Prepare RFPs and evaluate proposals based on the targeted product quality, project timeline, and budget.
• Plan and oversee drug substance process optimization, GMP manufacturing, and stability evaluation.
• Track process development/validation history and manage CMC drug substance related documents in support of life cycle of quality improvement and regulatory filing/updates.
• Work closely with a cross-functional team within and outside of the CMC department to align with key stakeholders (CMC, clinical, quality assurance and regulatory, etc.).
• Author and review CMC drug substance related sections for regulatory filing and annual updates.
• Stay current on industry trends and regulatory requirements to ensure delivery of quality products under non-GMP and GMP environments.
• Prepare and communicate research results in both oral and written format.
• Supervise junior CMC Drug Substance team members. 
• Contribute to a fast-paced, dynamic, data-driven scientific culture that embraces innovation and excellence.

• Ph.D. or M.S. in chemistry, chemical engineering, pharmaceutical science, or related discipline with at least 10 years of related experience (title for this position will be commensurate with the candidate’s experience and qualifications)
• Strong synthetic organic chemistry knowledge and problem-solving skills.
• In-depth knowledge of industry practices in drug substance manufacturing and supply.
• Desire and ability to maintain constructive working relationship with the CMC analytical development team and the CMC drug product team.
• In-depth knowledge of cGMP regulations and compliance.
• Track record of accomplishment in managing CMC drug substance projects at early and late development stages. 
• Direct experience with small molecule API NDA filing is preferred.
• Ability to enable external CRO/CDMO to achieve project goals on time and under budget.
• Strong written and communication skills, good problem-solving abilities, and an ability to work effectively with a diverse team of co-workers in a dynamic environment.