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:
ultrafocused – Work together to fearlessly uncover new possibilities
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:
- Lead and manage drug substance manufacturing for synthetic molecules and oligonucleotides in a cGMP environment, supporting both clinical and commercial supply.
- Oversee production planning, execution, and performance tracking to ensure reliable fulfillment of agreed manufacturing services.
- Manage and strengthen CMO relationships, including selection, onboarding, governance, and ongoing performance management.
- Lead or contribute to CMC projects across the small molecule and oligonucleotide portfolio, ensuring alignment with development and supply strategies.
- Author and/or provide expert input into CMC sections for global regulatory filings, including INDs, IMPDs, NDAs, and MAAs.
- Serve as an integral member of cross‑functional and cross‑discipline CMC teams for programs containing synthetic components.
- Oversee process development, optimization, technology transfer, and lifecycle management, including change controls, deviations, and investigations.
- Ensure development and maintenance of manufacturing-related documentation, including Design History Files and Quality Risk Management Plans.
- Drive RFPs, Statements of Work, Master Service Agreements, and other manufacturing and quality governance documents.
- Promote continuous improvement, knowledge management, and operational excellence while representing Drug Substance Manufacturing on global and cross‑functional teams.
Requirements:
- Ph.D. in chemistry, chemical engineering, organic chemistry, or a related discipline, or equivalent industry experience.
- 8–12 years of pharmaceutical or biopharmaceutical experience with progressive responsibility in CMC and manufacturing.
- Demonstrated experience in managing small molecule synthetic chemistry, pharmaceutical CMC development, process scale‑up, and cGMP manufacturing.
- Demonstrated experience managing and participating in cross‑functional CMC teams.
- Strong background in development and clinical manufacturing of small molecule drug substances; experience with oligonucleotides is a plus.
- Familiarity with QbD principles, DoE, process scale-up and optimization, validation/qualification, and phase‑appropriate controls.
- Solid knowledge of cGMP requirements, ICH guidelines, and phase‑appropriate controls..
- Familiarity with analytical development and quality control is advantageous.
- Strong track record of building and sustaining effective CMO partnerships.
- Demonstrated ability to lead teams, manage complexity, and deliver results in a matrixed environment.
- Excellent written and verbal communication skills in English; additional languages are a plus.
- 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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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.