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

• Highly experienced operations leader to support CMC development and manufacturing for Ultragenyx’s small molecule and oligonucleotide products as well as synthetic components integrated into other product platforms.
• The role requires leadership skills including CMC partnership, manufacturing, and CMO relationship management of various projects.
• Willing to learn and develop new areas of expertise and skill to support biologics development and manufacturing.
• This position will interact with several other CMC quality & regulatory functions in Ultragenyx and at CMOs, in addition to supply chain management, translational research, technical development, and clinical teams within the company.
  
  

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 small molecule external manufacturing, especially drug substance manufacturing, in a cGMP environment.
• Lead production planning, execution, and tracking. Ensure fulfillment of agreed manufacturing services for clinical and commercial supply.
• Manage CMO relationships and foster collaborative partnerships. Lead and/or contribute to CMO selection and onboarding.
• Support and/or lead CMC projects of Ultragenyx´s small molecule portfolio. Author and/or provide inputs to CMC sections in support global regulatory filings.
• Be an integral part of cross-functional and cross-discipline CMC teams for products that include synthetic components.
• Develop and maintain CMC manufacturing activities, QTPP (Quality Target Product Profile), Product Design History File and Quality Risk Management Plan.
• Drive required components of the CMC strategy to accomplish CMC team goals.
• Manage process development and optimization technology transfer as well as production related change control, deviation, and complaint.
• Drive RFPs, SOWs, MSAs, and other governance documents.
• Promote and implement knowledge management processes for appropriate sharing and storage of documentation.
• Provide strong representation on global projects and in functional and cross-functional teams.
  
  

Requirements:

• Ph.D. or equivalent in chemistry, chemical engineering, organic chemistry or related discipline with deep understanding of industry scale small molecule synthetic chemistry and demonstrable expertise in pharmaceutical CMC development, process scale-up and cGMP manufacturing, and supply chain management.
• 10+ years of relevant experience in small and/or large biopharmaceutical companies, and working in global organizations.
• Proven accomplishments and experience in cGMP manufacturing, external manufacturing, and working in a highly matrixed organization.
• Track record with ability to build and sustain effective CMO partnerships.
• Ability and experience to contribute to regulatory filing processes including INDs, IMPDs, NDAs, MAAs, and other regulatory related documents.
• Experience with analytical development and quality control is an advantage.
• Experienced in development and clinical manufacturing of small molecule drug substance as well as commercial launch and manufacturing. A background in medicinal chemistry and drug product manufacturing experience in various dosage forms are pluses.
• Demonstrated experience with participation in and/or leading CMC teams and executing CMC activities.
• Cross-functional experience a plus; willingness and ability to develop and learn.
• Ability to work with business systems and processes including legal, finance, quality, as well as manufacturing and supply chain operations.
• Good understanding of financial figures, cost management, and financial decision making.
• Experience in continuous improvement, operational and business process excellence projects.
• Excellent problem-solving skills as well as verbal and written communication skills in English are required. Skills in additional languages such as German are strongly welcomed.
• Travel approximately 25%
• Support Learning & Growth: Demonstrate self-awareness, humility, and curiosity in service of self-development. Provide regular coaching and feedback that will inspire growth and improvement in others.
  
  

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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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].