Associate Director - Senior Director, CMC Formulation Development

Company Overview

Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. The company brings together an accomplished management team and a distinguished scientific founder to translate research into novel therapeutics. With a proven track record of drug discovery and development—including multiple clinical‑stage compounds and an approved drug for the treatment of cancers and immune‑mediated inflammatory diseases—Kumquat is well positioned to make an impact in oncology.

We are seeking a highly motivated, creative CMC formulation professional at associate director or director level to join our CMC team in San Diego. The candidate will report to the Executive Director and Head of CMC and work closely with internal discovery and development teams and external CRO/CDMO partners to drive programs into early and late clinical development. The role involves formulation strategy design, process development, and manufacturing, with a focus on oral solid dosage and injectable formulations.

The candidate should be a strong team player, detail‑oriented, and eager to learn life‑cycle product management concepts.

• Understand the development candidate’s physicochemical properties and target product profile to evaluate formulation options and design phase‑appropriate formulations at different development stages.
• 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 product process optimization, GMP manufacturing, packaging, labeling, and stability testing activities.
• Track process development/validation history and manage CMC drug product related documents in support of the 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).
• Author and review CMC drug product related sections for regulatory filing and annual updates.
• Stay current on industry trends and regulatory requirements to ensure delivery of quality products under cGMP environment.
• Prepare and communicate research results in both oral and written format.
• Supervise junior CMC drug product 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 a related discipline with at least 10 years of industry experience (title for this position will be commensurate with the candidate’s experience and qualifications).
• Highly familiar with current formulation principles and industry practices.
• Extensive process development/optimization, scale‑up and process validation expertise, with emphasis on solid oral dosage forms.
• Experience with injectable formulations and modern enabling technologies is a plus.
• Track record of accomplishment in managing CMC drug product 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.
• 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: $170k–$275k.