Associate Director - Senior Director, CMC Formulation Development

Cmc Formulation Professional

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 founder 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 formulation professional at associate director or director level 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 formulation strategy design, process development and manufacturing. The ideal candidate will have an in-depth understanding in all aspects of oral solid dosage formulations and injectable formulations. 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

• 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, stability testing activities.
• Track process development/validation history and manage CMC drug product 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).
• 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.

Requirements

• Ph.D. or M.S. in chemistry, chemical engineering, pharmaceutical science, or 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 Description: $170k - $275k