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

Description

Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founders to translate innovative research to novel therapeutics. Our team has a proven track record of drug discovery and development, having played pivotal roles in the discovery of multiple clinical-stage compounds as well as an approved drug for the treatment of cancers and immune-mediated inflammatory diseases.

We are currently seeking a highly motivated, creative CMC drug substance professional to join our CMC team in San Diego. This candidate will report to the executive director and head of CMC. This candidate is expected to work closely with Kumquat internal discovery and development teams as well as external CRO/CDMO companies to drive programs into early and late clinical development. This is a position with responsibility for synthetic route design and scouting, process development and manufacturing. The ideal candidate will have an in-depth understanding in all aspects of modern synthetic chemistry, process development, and non-GMP/GMP manufacturing. A strong team player who is detail-oriented and has the desire to learn and understand life-cycle product management concepts and practice is essential. The candidate will have the opportunity to work on multiple programs within the company’s pipeline which comprises potentially first-in-class approaches & novel-novel targets.

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.
  
  

Requirements

• 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.
• Bilingual proficiency in English and Chinese (verbal and written) preferred but not required.
  
  

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

Salary Description: $180k - $200k