Hybrid Associate Director, Drug Substance Development

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

Benefits offered by this job

Onsite gym

Pool

Snacks and drinks

Occasional catered meals

Job summary

Tarsus Pharmaceuticals, Inc. in Irvine, CA is seeking an Associate Director, Chemical Development to lead CMC strategy for drug substance development and manufacturing across CMOs.

You will partner with Technical Operations, Pharmaceutical Sciences, and Regulatory to ensure compliant and timely production of clinical and commercial material, oversee technology transfer, scale-up, and vendor management, and contribute to regulatory filings.

Qualifications

• Ph.D. in technical operations or a related field with 8+ years of industrial experience.
• Experience with small-molecule or API development, CMOS oversight, and tech transfer.
• Strong cross-functional leadership and communication across technical and business teams.
• Ability to manage budgets, timelines, and external partners.

Responsibilities

• Oversee API operations across CMC programs at CMOs and ensure timelines and quality.
• Plan and execute CMO site selection, technology transfer, scale-up, and validation.
• Develop robust supply strategies and mitigate technical and operational risks.
• Ensure manufacturing activities comply with cGMP and regulatory filings; manage deviations.
• Develop and manage budgets and forecasts; monitor spend with finance.

Skills

Project management

Leadership

Cross-functional collaboration

Technical problem-solving

Regulatory understanding

Education

Ph.D. in Technical Operations, chemical development, process development, or pharmaceutical manufacturing support

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

Job description

Tarsus Pharmaceuticals, Inc. in Irvine, CA is seeking an Associate Director, Chemical Development to lead CMC strategy for drug substance development and manufacturing across CMOs.

You will partner with Technical Operations, Pharmaceutical Sciences, and Regulatory to ensure compliant and timely production of clinical and commercial material, oversee technology transfer, scale-up, and vendor management, and contribute to regulatory filings.