Associate Director, Drug Substance Development (Remote/Hybrid)

Tarsus Pharmaceuticals, Inc.; California (MO); Hybrid; USD 150,000 - 210,000; Full time

Benefits offered by this job

Onsite gym

Pool

Snacks & drinks

Catered meals

Hybrid work environment

Job summary

Tarsus Pharmaceuticals, Inc. in Irvine seeks an Associate Director, Chemical Development to guide CMC activities for drug substance development from preclinical through commercialization.

You will lead external manufacturing partners, ensure timelines, quality, and supply continuity for clinical and commercial products. Reporting to the Director of Chemical Development, you will coordinate with Regulatory, Analytical Development, Quality, and Supply Chain to support regulatory submissions and

Qualifications

• B.S., M.S., or Ph.D. in a relevant engineering or scientific discipline.
• Experience in drug substance development and pharmaceutical manufacturing.
• Experience overseeing CMO operations and technology transfer is preferred.

Responsibilities

• Manage API operations across CMC programs and oversee manufacture at CMOs.
• Plan manufacturing initiatives including site selection, tech transfer, scale-up, and validation.
• Develop robust supply strategies and mitigate technical/operational risks.
• Ensure cGMP compliance and lead investigations of deviations.
• Develop and manage budgets for assigned CMC activities and monitor spend.
• Contribute to CMC regulatory submissions and responses to health authorities.
• Collaborate with Regulatory Science and Pharmaceutical Sciences on development strategies.
• Review and approve batch records, protocols, reports, and changes as needed.
• Coordinate coverage and provide on-site or remote technical oversight.

Skills

Project management

Technical problem-solving

Cross-functional collaboration

Communication

Education

B.S., M.S., or Ph.D. in a relevant engineering or scientific discipline

Job description

Tarsus Pharmaceuticals, Inc. in Irvine seeks an Associate Director, Chemical Development to guide CMC activities for drug substance development from preclinical through commercialization.

You will lead external manufacturing partners, ensure timelines, quality, and supply continuity for clinical and commercial products. Reporting to the Director of Chemical Development, you will coordinate with Regulatory, Analytical Development, Quality, and Supply Chain to support regulatory submissions and