Associate Director, Drug Product Development
Mirum Pharmaceuticals, Inc.
August 25, 2026
Remote friendly (Foster City, CA)
United States
Clinical Research and Development
Position Summary
Mirum Pharmaceuticals is seeking an experienced Associate Director, Pharmaceutical Development to provide technical and strategic leadership for drug product development and manufacturing across clinical and commercial programs for small molecules. Lead formulation and process development, scale-up, technology transfer, validation, and lifecycle activities and provide technical oversight of external development and manufacturing partners.
Job Functions/Responsibilities
- Lead drug product formulation and process development, scale-up, technology transfer, process characterization, validation, and lifecycle management.
- Develop phase-appropriate strategies for clinical and commercial programs (scientific rigor, regulatory expectations, technical risk, timelines, cost).
- Interpret manufacturing, analytical, and stability data to identify trends, troubleshoot issues, and guide changes to formulations, processes, and control strategies.
- Provide technical leadership for GMP manufacturing (investigations, deviations, process optimization, continuous improvement).
- Lead technical oversight of CDMOs (development, manufacturing, tech transfer, validation, investigations, performance management).
- Partner with Quality, Supply Chain, and Regulatory CMC on product development, manufacturing, and regulatory strategy.
- Apply FDA/EMA/ICH/global regulatory expectations; support CMC regulatory submissions and health authority interactions.
- Communicate technical risks, recommendations, and business implications to cross-functional teams and senior leadership.
Qualifications
- Advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related field (or equivalent experience).
- 10+ years pharmaceutical/biotechnology industry experience with significant drug product development and GMP manufacturing.
- Demonstrated formulation/process development, scale-up, technology transfer, and process validation.
- Clinical and commercial manufacturing experience preferred.
Skills/Abilities
- Strong pharmaceutical analytical testing knowledge; ability to interpret analytical/stability/manufacturing data.
- Strong GMP, ICH, and regulatory understanding.
- CDMO management experience in outsourced environments.
- Scientific judgment; ability to influence Quality, Regulatory CMC, partners, and stakeholders.
- Business-oriented/pragmatic; balance risk, timeline, cost, and supply.
- Small company experience strongly preferred.
- Available for some teleconferences outside standard CA business hours.
- Travel up to 30%.
Compensation
- Salary range: $200,000 to $215,000 USD (base salary only unless otherwise provided).
Mirum Pharmaceuticals is seeking an experienced Associate Director, Pharmaceutical Development to provide technical and strategic leadership for drug product development and manufacturing across clinical and commercial programs for small molecules. Lead formulation and process development, scale-up, technology transfer, validation, and lifecycle activities and provide technical oversight of external development and manufacturing partners.
Job Functions/Responsibilities
- Lead drug product formulation and process development, scale-up, technology transfer, process characterization, validation, and lifecycle management.
- Develop phase-appropriate strategies for clinical and commercial programs (scientific rigor, regulatory expectations, technical risk, timelines, cost).
- Interpret manufacturing, analytical, and stability data to identify trends, troubleshoot issues, and guide changes to formulations, processes, and control strategies.
- Provide technical leadership for GMP manufacturing (investigations, deviations, process optimization, continuous improvement).
- Lead technical oversight of CDMOs (development, manufacturing, tech transfer, validation, investigations, performance management).
- Partner with Quality, Supply Chain, and Regulatory CMC on product development, manufacturing, and regulatory strategy.
- Apply FDA/EMA/ICH/global regulatory expectations; support CMC regulatory submissions and health authority interactions.
- Communicate technical risks, recommendations, and business implications to cross-functional teams and senior leadership.
Qualifications
- Advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related field (or equivalent experience).
- 10+ years pharmaceutical/biotechnology industry experience with significant drug product development and GMP manufacturing.
- Demonstrated formulation/process development, scale-up, technology transfer, and process validation.
- Clinical and commercial manufacturing experience preferred.
Skills/Abilities
- Strong pharmaceutical analytical testing knowledge; ability to interpret analytical/stability/manufacturing data.
- Strong GMP, ICH, and regulatory understanding.
- CDMO management experience in outsourced environments.
- Scientific judgment; ability to influence Quality, Regulatory CMC, partners, and stakeholders.
- Business-oriented/pragmatic; balance risk, timeline, cost, and supply.
- Small company experience strongly preferred.
- Available for some teleconferences outside standard CA business hours.
- Travel up to 30%.
Compensation
- Salary range: $200,000 to $215,000 USD (base salary only unless otherwise provided).