Kumquat Biosciences Inc. · 2 months ago
Director / Senior Director, CMC Formulation Development
Kumquat Biosciences
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$220K/yr - $240K/yr
10+ years expKumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. They are seeking a highly motivated CMC formulation professional at the associate director or director level to join their CMC team in San Diego, focusing on formulation strategy design, process development, and manufacturing.
Alternative MedicineBiotechnologyOncologyTherapeutics
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
Qualification
Required
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
Benefits
Equity incentives
Company
Kumquat Biosciences Inc.
Kumquat Biosciences’ vision is to develop innovative therapies to bring about sustainable and life-changing benefits to cancer patients.
11-50 employees
H1B Sponsorship
Kumquat Biosciences Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (1)
2022 (2)
2021 (2)
Funding
Current Stage
Early StageTotal Funding
$175.92MKey Investors
Loxo Oncology
2021-07-29Corporate Round· $70M
2021-02-16Undisclosed· $50M
2019-07-02Private Equity· $55.92M
Leadership Team
Pingda Ren
Co-Founder, President & COO
Carin Sandvik
VP of Finance
Recent News
Labiotech.eu
2025-09-12
2025-08-17
Company data provided by crunchbase