Director Chemical Manufacturing
Director Chemical Manufacturing
Posted on :
04-05-2025
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1 Vacancy
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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 achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont go challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from lifechanging 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 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 andpersonally 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 Ultragenyxs 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 23 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 Ultragenyxs small molecule portfolio. Author and/or provide inputs to CMC sections in support global regulatory filings.
- Be an integral part of crossfunctional and crossdiscipline 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 crossfunctional 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 scaleup 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.
- Crossfunctional 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 problemsolving 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 selfawareness humility and curiosity in service of selfdevelopment. Provide regular coaching and feedback that will inspire growth and improvement in others. #LICT1 #LIHybrid
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 .
See ourCCPA Employee and Applicant Privacy Notice.
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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:.
Required Experience:
Director
Employment Type
Full Time
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