Associate Director, Drug Product Development at Mirum Pharmaceuticals

Job description

MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. 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. This individual will lead formulation and process development, scale-up, technology transfer, validation, and lifecycle activities while providing technical oversight of external development and manufacturing partners. The ideal candidate combines strong pharmaceutical development expertise with sound scientific judgment and a pragmatic, business-oriented approach. This role requires the ability to integrate formulation, manufacturing, analytical, quality, supply chain, and regulatory considerations to make well-informed development and manufacturing decisions. JOB FUNCTIONS/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 scientific rigor, regulatory expectations, technical risk, timelines, and cost. Interpret manufacturing, analytical, and stability data to identify trends, troubleshoot issues, and guide appropriate 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, technology transfer, validation, investigations, and performance management. Partner closely with Quality, Supply Chain and Regulatory CMC to develop scientifically sound and pragmatic approaches to product development, manufacturing, and regulatory strategy. Apply knowledge of relevant FDA, EMA, ICH, and global regulatory expectations to development and manufacturing decisions and support CMC regulatory submissions and health authority interactions. Communicate technical risks, recommendations, and business implications effectively to cross-functional teams and senior leadership. QUALIFICATIONS Education /Experience: Advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related discipline; equivalent relevant experience will be considered. 10+ years of pharmaceutical/biotechnology industry experience with significant experience in drug product development and GMP manufacturing. Demonstrated experience with formulation and process development, scale-up, technology transfer, and process validation. Experience supporting both clinical-stage development and commercial manufacturing preferred. Knowledge, Skills and Abilities: Strong working knowledge of pharmaceutical analytical testing and demonstrated ability to interpret analytical, stability, and manufacturing data to drive technical decisions. Strong understanding of GMP requirements, ICH guidelines, and regulatory expectations for pharmaceutical development and manufacturing. Demonstrated experience managing CDMOs and working effectively in an outsourced development and manufacturing environment. Strong scientific judgment with the ability to constructively challenge assumptions and influence Quality, Regulatory CMC, external partners, and cross-functional stakeholders. Business-oriented and pragmatic, with the ability to balance technical requirements with risk, timeline, cost, and supply considerations. Experience in a small company environment strongly preferred. Must be available for some teleconferences outside of standard California business hours. Ability to travel up to 30% of time required. The salary range for this position is $200,000 to $215,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided. #LI-HYBRID Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws. Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

Requirements

Must-haves

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 scientific rigor, regulatory expectations, technical risk, timelines, and cost.
Interpret manufacturing, analytical, and stability data to identify trends, troubleshoot issues, and guide appropriate 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, technology transfer, validation, investigations, and performance management.
Partner closely with Quality, Supply Chain and Regulatory CMC to develop scientifically sound and pragmatic approaches to product development, manufacturing, and regulatory strategy.
Apply knowledge of relevant FDA, EMA, ICH, and global regulatory expectations to development and manufacturing decisions and support CMC regulatory submissions and health authority interactions.
Communicate technical risks, recommendations, and business implications effectively to cross-functional teams and senior leadership.
Advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related discipline; equivalent relevant experience will be considered.
10+ years of pharmaceutical/biotechnology industry experience with significant experience in drug product development and GMP manufacturing.
Demonstrated experience with formulation and process development, scale-up, technology transfer, and process validation.
Strong working knowledge of pharmaceutical analytical testing and demonstrated ability to interpret analytical, stability, and manufacturing data to drive technical decisions.
Strong understanding of GMP requirements, ICH guidelines, and regulatory expectations for pharmaceutical development and manufacturing.
Demonstrated experience managing CDMOs and working effectively in an outsourced development and manufacturing environment.
Strong scientific judgment with the ability to constructively challenge assumptions and influence Quality, Regulatory CMC, external partners, and cross-functional stakeholders.
Business-oriented and pragmatic, with the ability to balance technical requirements with risk, timeline, cost, and supply considerations.
Must be available for some teleconferences outside of standard California business hours.
Ability to travel up to 30% of time required.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

Nice-to-haves

Experience supporting both clinical-stage development and commercial manufacturing preferred.
Experience in a small company environment strongly preferred.

Application prep

Use the role’s language and application details while tailoring your materials.

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