Director / Senior Director, CMC API Process Development and Manufacturing

$130,000 - $225,000/Yr

Kumquat Biosciences - San Diego, CA

Full-time - Senior

San Diego, CA

Professional, Scientific, and Technical Services

About the position

Kumquat Biosciences is seeking a highly motivated and creative CMC drug substance professional to join their CMC team in San Diego. This role involves working closely with internal discovery and development teams as well as external CRO/CDMO companies to drive programs into early and late clinical development. The candidate will be responsible for synthetic route design, process development, and manufacturing, requiring a deep understanding of modern synthetic chemistry and GMP practices. The position offers the opportunity to work on multiple innovative programs within the company's pipeline.

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.

Requirements

• Ph.D. or M.S. in chemistry, chemical engineering, pharmaceutical science, or related discipline with at least 10 years of related experience.
• 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.
• 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.

Benefits

• Attractive salary and benefits package
• Equity incentives