Director, Oligonucleotide Process Development

Position Summary:

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The Director of Oligonucleotide Process Development provides independent technical leadership for oligonucleotide and small molecule drug substance development activities, including process development, scaleup, technology transfer, and GMP manufacturing. The role supports multiple development programs from preIND through NDA submission and serves as a core member of CMC program teams.

This position requires deep expertise in oligonucleotide and small molecule synthesis, purification technologies, and analytical methods, along with a strong understanding of cGMP requirements, CMC control strategies, and global regulatory expectations. The Director operates with a high degree of autonomy, manages complex external partnerships, and is accountable for technical execution, risk mitigation, and regulatory readiness.

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 drug substance process development, optimization, scaleup, technology transfer, process characterization, validation, and manufacturing support for ASO, siRNA, and smallmolecule programs within Ultragenyx’s pipeline.
2. Provide technical leadership and expert oversight for oligonucleotide (ASO) process development and manufacturing activities conducted at CROs, CMOs, and CDMOs.
3. Serve as a core technical contributor within crossfunctional CMC project teams, driving execution of program milestones on schedule and within budget.
4. Lead or actively participate in the selection, evaluation, and governance of external partners, ensuring delivery of highquality, compliant work packages.
5. Author, review, and approve drug substance–related sections of IND, IMPD, NDA, and MAA submissions.
6. Support Manufacturing, Quality, and Supply Chain teams in deviation investigations, rootcause analysis, change management, and product lifecycle activities.
7. Act as a technical subjectmatter expert for Research and Business Development initiatives, including technical assessments and due diligence support as needed.
8. Prepare and manage program budgets; develop and issue RFPs; review and approve work orders; and partner with Legal and Quality to establish and maintain MSAs and QTAs.
9. Draft, review, and approve drug substance technical documentation, including process development reports, master batch records, campaign reports, validation documentation, and change controls.
10. Oversee review of executed batch records and provide technical input supporting batch disposition and release decisions. Support resolution of manufacturing deviations and events.
11. Ensure all activities are conducted in compliance with internal policies, cGMP requirements, and applicable global regulatory standards and guidelines. Maintain current knowledge of relevant pharmaceutical regulations.
12. Manage all ASO regulatory starting material and drug substance development activities conducted internally and at external CDMO partners, including route scouting, process research and development (PRD), scaleup, and nGMP/GMP manufacturing.

Requirements:

• PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline with 10+ years of relevant pharmaceutical industry experience; or MS with 12+ years; or BS with 15+ years, including demonstrated technical or matrix leadership experience.

• Minimum 8 years of experience in oligonucleotide drug substance development, including largescale synthesis and purification.

• Proven track record in ASO process development, manufacturing, technology transfer, and end-to-end ownership of the DS control strategy.

• Strong working knowledge of IND/IMPD/NDA/MAA submissions and global regulatory and quality requirements, including ICH guidelines.

• Extensive experience selecting, managing, and collaborating with CROs/CMOs/CDMOs in an outsourced development environment.

• Demonstrated ability to lead complex, crossfunctional technical initiatives and manage multiple external partners concurrently.

• Strong problemsolving skills with excellent written and verbal communication abilities.

• Experience in applying Design of Experiments (DoE) and statistical tools to process development and optimization.

• Experience supporting both earlystage and latestage drug substance development, including GMP manufacturing.

• Willingness to travel up to 15%.

Physical Demand Requirements

• Sitting and tand for extended periods of time with periodic stooping / bending / kneeling

• Able to lift, push, pull up to 25lbs.

• Climb ladders and stairs of various heights.

• Domestic and international travel up to 15%

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