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Salary: USD 200,000 - 215,000 / annual
Mirum Pharmaceuticals, a biopharmaceutical company focused on rare disease treatments, seeks an Associate Director of Drug Product Development to lead pharmaceutical development and manufacturing strategy for small-molecule programs. This role combines technical expertise with strategic leadership across clinical and commercial phases.
Key responsibilities include leading drug product formulation and process development from conception through commercial scale-up, including technology transfer, process characterization, and validation. You will develop phase-appropriate development strategies that balance scientific rigor, regulatory requirements, technical risk, timelines, and cost considerations. The role requires interpreting manufacturing, analytical, and stability data to identify trends, troubleshoot manufacturing issues, and guide formulation and process improvements.
You will provide technical leadership for GMP manufacturing activities, investigations, deviations, and continuous improvement initiatives. A critical component is managing relationships with contract development and manufacturing organizations (CDMOs), including oversight of development, manufacturing, technology transfer, validation, and performance management. You will partner closely with Quality, Supply Chain, and Regulatory CMC teams to develop scientifically sound and pragmatic approaches to product development and regulatory strategy.
The role requires applying knowledge of FDA, EMA, ICH, and global regulatory expectations to inform development and manufacturing decisions, and supporting CMC regulatory submissions and health authority interactions. You will communicate technical risks, recommendations, and business implications effectively to cross-functional teams and senior leadership.
Required qualifications include an advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related discipline (or equivalent experience), plus 10+ years in pharmaceutical/biotechnology with significant drug product development and GMP manufacturing experience. Demonstrated expertise in formulation and process development, scale-up, technology transfer, and process validation is essential. Experience supporting both clinical-stage and commercial manufacturing is preferred.
You must have strong working knowledge of pharmaceutical analytical testing and the ability to interpret analytical, stability, and manufacturing data. Understanding of GMP requirements, ICH guidelines, and regulatory expectations is critical. Demonstrated CDMO management experience and ability to work effectively in outsourced environments is required. Strong scientific judgment, ability to challenge assumptions constructively, and influence across functions are essential. A pragmatic, business-oriented mindset that balances technical requirements with risk, timeline, cost, and supply considerations is key. Small company experience is strongly preferred. Travel up to 30% and availability for teleconferences outside standard California business hours required.
