Senior Director Pharmaceutical (Drug Product) Manufacturing

Position Summary:

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The Senior Director, Drug Product Manufacturing is an experienced operations leader responsible for CMC development and GMP manufacturing of Ultragenyx’s drug product formulations, including small molecule and oligonucleotide products. This role leads external drug product manufacturing activities, supports reliable clinical and commercial supply, and contributes to strategic planning within Technical Operations. The position serves as a recognized technical expert and partners cross‑functionally across Quality, Regulatory, Supply Chain, and Development organizations. 

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. Lead external drug product manufacturing for small molecule and oligonucleotide products in a cGMP environment. 
2. Oversee production planning, execution, and performance tracking to ensure clinical and commercial supply commitments are met. 
3. Manage CMO relationships, including selection, onboarding, and performance management, fostering strong collaborative partnerships. 
4. Lead or support CMC activities across the drug product portfolio, including authoring and reviewing CMC sections for global regulatory filings (INDs, IMPDs, NDAs, MAAs). 
5. Serve as an integral member of cross‑functional CMC teams, partnering with Quality, Regulatory, Supply Chain, Development, and Clinical teams. 
6. Develop and maintain manufacturing documentation, including Product Design History Files and Quality Risk Management Plans. 
7. Oversee process development, technology transfer, process optimization, and lifecycle management activities. 
8. Manage manufacturing-related deviations, change controls, investigations, and complaint responses. 
9. Drive RFPs, Statements of Work, Master Service Agreements, and other manufacturing governance documents. 
10. Promote knowledge management, documentation best practices, continuous improvement, and operational excellence initiatives while representing Drug Product Manufacturing on global and cross‑functional teams. 

Requirements:

1. PhD or equivalent relevant experience in Pharmaceutical Sciences, Engineering, or related discipline. 
2. 10–15+ years of experience in pharmaceutical or biopharmaceutical manufacturing, preferably within global organizations. 
3. Demonstrated expertise in small molecule drug product development and clinical/commercial manufacturing; experience with multiple dosage forms preferred. 
4. Strong knowledge of QbD, DoE, process validation/qualification, phase‑appropriate manufacturing controls, PAT, and current regulatory expectations for drug products. 
5. Working knowledge of cGMP, ICH guidelines, and global regulatory submission requirements. 
6. Proven track record managing and sustaining effective CMO partnerships in a matrixed organization. 
7. Experience with analytical development and quality control is a plus. 
8. Strong problem‑solving, leadership, communication, and financial acumen. 
9. Commitment to coaching, feedback, and continuous learning and development.  

Physical Demand Requirements   

Office‑based role with occasional presence in manufacturing and partner facilities. requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body may be required during site visits or when attending as person-in-plant. This requires the ability to change clothes into appropriate gowning and personal protective equipment.  

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