Why Join Us?
Be a hero for our rare disease patients
At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.
Position Summary:
ultrainnovative – Tackle rare and dynamic challenges
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.
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:
- 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.
- Provide technical leadership and expert oversight of drug substance process development and manufacturing activities conducted at CROs, CMOs, and CDMOs.
- Serve as a core technical contributor within cross‑functional CMC project teams, driving execution of program milestones on schedule and within budget.
- Lead or actively support selection, evaluation, and governance of external partners, ensuring delivery of high‑quality, compliant work packages.
- Author/ Co- author, review, drug substance–related sections of IND, IMPD, NDA, and MAA submissions.
- Support Manufacturing, Quality, and Supply Chain teams in deviation investigations, root‑cause analysis, change management, and product lifecycle activities.
- 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.
- 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.
- 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
- 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.
Requirements:
- 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%
#LI-CT1 #LI-Hybrid
Full Time employees across the globe enjoy a range of benefits, including, but not limited to:
· Generous vacation time and public holidays observed by the company
· Volunteer days
· Long term incentive and Employee stock purchase plans or equivalent offerings
· Employee wellbeing benefits
· Fitness reimbursement
· Tuition sponsoring
· Professional development plans
* Benefits vary by region and country
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to
: talentacquisition@ultragenyx.com.