Associate Director, Small Molecule Process Development

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The Associate Director of Small Molecule Process Development provides independent technical leadership for drug substance development activities, including process development, synthetic route design, scale‑up, technology transfer, GMP manufacturing and PPQ activities. The role may support multiple early phase development programs and serve as a member of CMC program teams, and working closely with the Analytical Development, Quality, Supply Chain, External Manufacturing, and Regulatory CMC groups. 

This position requires expertise in small molecule development and manufacturing, crystallization, and modern manufacturing technologies for control of polymorph and particle size, analytical methods, along with a strong understanding of cGMP requirements, familiarity with CMC control strategy, and global regulatory expectations. The Associate Director manages complex external partnerships, and is accountable for technical execution, risk mitigation, and regulatory readiness.  

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.

1. Lead synthetic small molecule drug substance process development from pre-IND to phase 3. Activities include route scouting, optimization, scale‑up, technology transfer, control strategy, process characterization, impurities F&P, PPQ, and manufacturing support for small molecule programs within Ultragenyx’s pipeline. 
2. Provide technical leadership and expert oversight of drug substance process development and manufacturing activities conducted at CROs, CMOs, and CDMOs. 
3. Serve as a core technical contributor within cross‑functional CMC project teams, driving execution of program milestones on schedule and within budget. 
4. Lead or actively support selection, evaluation, and governance of external partners, ensuring delivery of high‑quality, compliant work packages. 
5. Author/ Co- author, review, drug substance–related sections of IND, IMPD, NDA, and MAA submissions. 
6. Support Manufacturing, Quality, and Supply Chain teams in deviation investigations, root‑cause analysis, change management, and product lifecycle activities. 
7. 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. 
8. Draft, review, and approve drug substance technical documentation and reports, including process development and characterization, control strategy, master batch records, campaign report, validation documentation, and change controls. 
9. Review executed batch records and provide technical input supporting batch disposition and release decisions. Support resolution of manufacturing deviations and events. 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 
10. Manage all small molecule regulatory starting material and drug substance development activities conducted at external CDMO partners, including synthetic route design, process research and development (PRD), scale‑up, and manufacturing. 

• PhD in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline with minimum 6+ years of relevant pharmaceutical industry experience; or MS with 8+ years; or BS with 10+ years, including demonstrated technical or matrix leadership experience. 
• Demonstrated track record with extensive hands-on experience in small molecule drug substance development, including process development, GMP kilo-lab operations, and successful technology transfer to commercial manufacturing scale. Proven expertise in synthetic route design and optimization, control strategy development, process characterization, and impurity identification and control. 

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

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

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

• Strong problem‑solving skills with excellent written and verbal communication abilities. 

• Experience in applying Design of Experiments (DoE) and statistical tools to process development and optimization, participation or leading process validation /PPQ, and conjugation chemistry are highly desired.  

• Experience supporting both early‑stage and late‑stage drug substance development, including GMP manufacturing. 

• Willingness to travel up to 20%. 

Physical Demand Requirements  

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

• Occasionally may require to work in a controlled environment requiring gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment. 

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

• Climb ladders and stairs of various heights. 
• Domestic and international travel up to 20% 

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