Director Chemical (Drug Substance) Manufacturing Management

Position Summary:

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The Director, Drug Substance Manufacturing provides technical and operational leadership for drug substance manufacturing activities supporting Ultragenyx’s small molecule and oligonucleotide programs. This role is responsible for execution of departmental manufacturing strategies, management of external CMOs, and delivery of reliable clinical and commercial supply under cGMP conditions. The Director partners cross‑functionally to ensure safe, compliant, and efficient manufacturing while operating within established functional strategies.

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 and manage drug substance manufacturing for synthetic molecules and oligonucleotides in a cGMP environment, supporting both clinical and commercial supply.
2. Oversee production planning, execution, and performance tracking to ensure reliable fulfillment of agreed manufacturing services.
3. Manage and strengthen CMO relationships, including selection, onboarding, governance, and ongoing performance management.
4. Lead or contribute to CMC projects across the small molecule and oligonucleotide portfolio, ensuring alignment with development and supply strategies.
5. Author and/or provide expert input into CMC sections for global regulatory filings, including INDs, IMPDs, NDAs, and MAAs.
6. Serve as an integral member of cross‑functional and cross‑discipline CMC teams for programs containing synthetic components.
7. Oversee process development, optimization, technology transfer, and lifecycle management, including change controls, deviations, and investigations.
8. Ensure development and maintenance of manufacturing-related documentation, including Design History Files and Quality Risk Management Plans.
9. Drive RFPs, Statements of Work, Master Service Agreements, and other manufacturing and quality governance documents.
10. Promote continuous improvement, knowledge management, and operational excellence while representing Drug Substance Manufacturing on global and cross‑functional teams.

Requirements:

1. Ph.D. in chemistry, chemical engineering, organic chemistry, or a related discipline, or equivalent industry experience.
2. 8–12 years of pharmaceutical or biopharmaceutical experience with progressive responsibility in CMC and manufacturing.
3. Demonstrated experience in managing small molecule synthetic chemistry, pharmaceutical CMC development, process scale‑up, and cGMP manufacturing.
4. Demonstrated experience managing and participating in cross‑functional CMC teams.
5. Strong background in development and clinical manufacturing of small molecule drug substances; experience with oligonucleotides is a plus.
6. Familiarity with QbD principles, DoE, process scale-up and optimization, validation/qualification, and phase‑appropriate controls.
7. Solid knowledge of cGMP requirements, ICH guidelines, and phase‑appropriate controls..
8. Familiarity with analytical development and quality control is advantageous.
9. Strong track record of building and sustaining effective CMO partnerships.
10. Demonstrated ability to lead teams, manage complexity, and deliver results in a matrixed environment.
11. Excellent written and verbal communication skills in English; additional languages are a plus.
12. Demonstrated commitment to leadership development, coaching, and continuous learning.

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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