Senior Drug Product Development Lead

Mirum Pharmaceuticals; Foster City (CA); On-site; USD 200,000 - 215,000; Full time

Job summary

Mirum Pharmaceuticals, located in Foster City, CA, seeks an experienced Associate Director of Drug Product Development to lead formulation, process development, scale‑up, technology transfer, and lifecycle activities across clinical and commercial programs.

You will integrate formulation, manufacturing, analytical, quality, supply chain and regulatory inputs to drive decisions while providing oversight of external partners and ensuring regulatory readiness.

Qualifications

• Advanced degree in Pharmaceutical Sciences or related field.
• 10+ years of pharma/biotech industry experience.
• Experience in drug product development and GMP manufacturing.
• Experience with formulation/process development, scale-up, technology transfer and process validation.

Responsibilities

• Lead drug product formulation and process development, scale-up, technology transfer, process characterization, validation and lifecycle management activities.
• Develop phase-appropriate strategies for clinical and commercial programs balancing science, regulatory expectations, risk, timelines and cost.
• Interpret manufacturing, analytical and stability data to identify trends and guide changes to formulations, processes and control strategies.
• Provide technical leadership for GMP manufacturing activities, investigations, deviations, process optimization and continuous improvement.
• Lead technical oversight of CDMOs including development, manufacturing, tech transfer, validation, investigations and performance management.
• Partner with Quality, Supply Chain and Regulatory CMC to develop pragmatic approaches to product development, manufacturing and regulatory strategy.
• Apply knowledge of FDA/EMA/ICH and global regulatory expectations to development and manufacturing decisions and support CMC submissions and health authority interactions.
• Communicate technical risks, recommendations and business implications to cross-functional teams and senior leadership.

Skills

Analytical testing knowledge

GMP/ICH regulatory knowledge

CDMO management

Cross-functional collaboration

Commercial manufacturing experience

Teleconferences outside CA hours

Travel up to 30%

Education

Advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry or related

10+ years pharma/biotech experience

Job description

Mirum Pharmaceuticals, located in Foster City, CA, seeks an experienced Associate Director of Drug Product Development to lead formulation, process development, scale‑up, technology transfer, and lifecycle activities across clinical and commercial programs.

You will integrate formulation, manufacturing, analytical, quality, supply chain and regulatory inputs to drive decisions while providing oversight of external partners and ensuring regulatory readiness.