Associate Director​/Senior Director, CMC API Process Development and Manufacturing

Director / Senior Director, CMC API Process Development and Manufacturing

Join to apply for the Director / Senior Director, CMC API Process Development and Manufacturing role at Kumquat Biosciences Inc.

Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Our team has a proven track record in drug discovery and development, including clinical-stage compounds and an approved drug for cancers and immune-mediated inflammatory diseases. We are seeking a highly motivated, creative CMC drug substance professional to join our CMC team in San Diego. This role reports to the Senior Director and Head of CMC and involves collaboration with internal discovery and development teams as well as external CRO/CDMO partners to drive programs into early and late clinical development.

• 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 their technical capabilities, quality systems, and track records.
• Prepare RFPs and evaluate proposals based on 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 lifecycle improvements and regulatory filing/updates.
• Collaborate with cross-functional teams (CMC, clinical, quality assurance, regulatory, etc.) to align on projects and milestones.
• Author and review CMC drug substance sections for regulatory filing and annual updates.
• Stay current on industry trends and regulatory requirements to ensure quality in non-GMP and GMP environments.
• Prepare and communicate research results in oral and written formats.
• Supervise junior CMC Drug Substance team members.
• Contribute to a fast-paced, data-driven scientific culture that emphasizes 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 commensurate with experience).
• Strong synthetic organic chemistry knowledge and problem-solving skills.
• In-depth knowledge of industry practices in drug substance manufacturing and supply.
• Ability to maintain constructive working relationships with CMC analytical development and CMC drug product teams.
• In-depth knowledge of cGMP regulations and compliance.
• Track record of 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 verbal communication skills, good problem-solving abilities, and ability to work effectively with a diverse team in a dynamic environment.

Kumquat Biosciences offers an attractive salary and benefits package, including equity incentives.

Salary

Description:

$185k-$250k

• Seniority level:
  Director
• Employment type:
  
  Full-time
• Job function:
  Other