Senior Director Pharmaceutical Drug Product Manufacturing

Job Description

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:

ultra focused – Work together to fearlessly uncover new possibilities

The Senior Director, Drug Product Manufacturing is an experienced operations leader responsible for CMC development and GMP manufacturing of Ultragenyx’s drug product formulations, including small molecule and oligonucleotide products. This role leads external drug product manufacturing activities, supports reliable clinical and commercial supply, and contributes to strategic planning within Technical Operations. The position serves as a recognized technical expert and partners cross‑functionally across Quality, Regulatory, Supply Chain, and Development organizations.

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 external drug product manufacturing for small molecule and oligonucleotide products in a cGMP environment.
2. Oversee production planning, execution, and performance tracking to ensure clinical and commercial supply commitments are met.
3. Manage CMO relationships, including selection, onboarding, and performance management, fostering strong collaborative partnerships.
4. Lead or support CMC activities across the drug product portfolio, including authoring and reviewing CMC sections for global regulatory filings (INDs, IMPDs, NDAs, MAAs).
5. Serve as an integral member of cross‑functional CMC teams, partnering with Quality, Regulatory, Supply Chain, Development, and Clinical teams.
6. Develop and maintain manufacturing documentation, including Product Design History Files and Quality Risk Management Plans.
7. Oversee process development, technology transfer, process optimization, and lifecycle management activities.
8. Manage manufacturing-related deviations, change controls, investigations, and complaint responses.
9. Drive RFPs, Statements of Work, Master Service Agreements, and other manufacturing governance documents.
10. Promote knowledge management, documentation best practices, continuous improvement, and operational excellence initiatives while representing Drug Product Manufacturing on global and cross‑functional teams.

Requirements:

1. PhD or equivalent relevant experience in Pharmaceutical Sciences, Engineering, or related discipline.
2. 10–15+ years of experience in pharmaceutical or biopharmaceutical manufacturing, preferably within global organizations.
3. Demonstrated expertise in small molecule drug product development and clinical/commercial manufacturing; experience with multiple dosage forms preferred.
4. Strong knowledge of QbD, DoE, process validation/qualification, phase‑appropriate manufacturing controls, PAT, and current regulatory expectations for drug products.
5. Working knowledge of cGMP, ICH guidelines, and global regulatory submission requirements.
6. Proven track record managing and sustaining effective CMO partnerships in a matrixed organization.
7. Experience with analytical development and quality control is a plus.
8. Strong problem‑solving, leadership, communication, and financial acumen.
9. Commitment to coaching, feedback, and continuous learning and development.

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.

#LI-CT1 #LI-Hybrid

The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant’s geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Pay Range

$251,300—$310,500 USD

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 [email protected] .

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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 : [email protected] .