Associate Director, Drug Substance Development (Hybrid & Equity)

Welcome to the Tarsanet Internal Career Center!; Irvine (CA); Hybrid; USD 150,000 - 210,000; Full time

Benefits offered by this job

Hybrid work environment

Bonus

Stock options

Comprehensive benefits

Job summary

Tarsus is seeking an Associate Director of Chemical Development in Irvine, CA to lead strategic planning and execution of CMC activities for drug substance development across CMOs. You will partner with Regulatory Science, Pharmaceutical Sciences, and Quality to ensure supply continuity and regulatory readiness.

The role demands extensive experience in process development, tech transfer, scale-up, and cross-functional leadership within a fast-paced biotech environment.

Qualifications

• Extensive understanding of drug substance development and pharmaceutical manufacturing.
• Experience with sterile product programs and related manufacturing operations preferred.
• Qualifications align with progressive industrial leadership in CMC settings.

Responsibilities

• Oversee API operations across CMC programs and manage CMOs to meet timelines and quality.
• Plan CMOs site selection, technology transfer, scale-up, process development, validation, and production.
• Develop robust supply strategies and mitigate risks aligned with development timelines.
• Ensure manufacturing activities comply with cGMP and regulatory filings; manage deviations.
• Develop budgets and forecasts for CMC activities; monitor spend and variances.
• Collaborate on regulatory submissions and responses to health authorities.
• Coordinate on-site or remote technical oversight of manufacturing activities.

Skills

Process development

Scale-up

Technology transfer

CMO oversight

Regulatory submissions

Project management

Cross-functional leadership

Communication

Decision making

Collaboration

Outcome oriented

Quality systems

Education

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

Ph.D. in Technical Operations, chemical development, process development, or pharmaceutical manufacturing support with 8+ years

B.S. with 12+ years experience

M.S. with 10+ years experience

Job description

Tarsus is seeking an Associate Director of Chemical Development in Irvine, CA to lead strategic planning and execution of CMC activities for drug substance development across CMOs. You will partner with Regulatory Science, Pharmaceutical Sciences, and Quality to ensure supply continuity and regulatory readiness.

The role demands extensive experience in process development, tech transfer, scale-up, and cross-functional leadership within a fast-paced biotech environment.