Is the Associate Director, Drug Product Development role remote?

It's hybrid — Mirum Pharmaceuticals expects some on-site time in Foster City.

What's the salary range?

Mirum Pharmaceuticals lists $200,000–$215,000 for this role.

How much experience is required?

At least 10 years of relevant experience for this Associate Director, Drug Product Development role.

Where is the role based?

Mirum Pharmaceuticals is hiring for this position in Foster City.

What seniority level is this role?

Mirum Pharmaceuticals targets director candidates for this position.

Is this full-time or contract?

Full-time for this Associate Director, Drug Product Development role at Mirum Pharmaceuticals.

Associate Director, Drug Product Development at Mirum Pharmaceuticals

Joblaze summary

The Associate Director of Drug Product Development at Mirum Pharmaceuticals is responsible for leading the formulation and process development of small molecule drugs, overseeing both clinical and commercial manufacturing activities. This role requires a deep understanding of pharmaceutical development, GMP manufacturing, and regulatory compliance, along with strong analytical skills to interpret data and guide decision-making. Ideal candidates will have over ten years of relevant experience, particularly in a small company setting, and a pragmatic approach to balancing technical and business considerations.

Joblaze insights

Listed 9 days ago on Joblaze — tracked directly from Mirum Pharmaceuticals's career page.
Mirum Pharmaceuticals has 81 other open roles including Senior Director, IT - G&A, Regional Account Manager, North Spain - Hepatology, Therapeutic Account Manager, Liver - Detroit.
Salary band is above the typical range for comparable tech roles (median ~$126,887).

Quick facts

Is the Associate Director, Drug Product Development role remote?: It's hybrid — Mirum Pharmaceuticals expects some on-site time in Foster City.
What's the salary range?: Mirum Pharmaceuticals lists $200,000–$215,000 for this role.
How much experience is required?: At least 10 years of relevant experience for this Associate Director, Drug Product Development role.
Where is the role based?: Mirum Pharmaceuticals is hiring for this position in Foster City.
What seniority level is this role?: Mirum Pharmaceuticals targets director candidates for this position.
Is this full-time or contract?: Full-time for this Associate Director, Drug Product Development role at Mirum Pharmaceuticals.

From the original posting

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.

Associate Director, Drug Product Development

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