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

We are seeking a highly motivated and experienced individual to lead analytical development for Ultragenyx‘s small molecule products. This position will report to the Director of Analytical Development in Technical Development, and represent analytical development function in CMC development teams to enable successful regulatory filings of new products.

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 analytical method development / transfer of small molecule drug substance, key starting materials, intermediates, drug product, and oral solid dosage form. Be an integral part of cross-functional and cross-discipline CMC teams for small molecule products to deliver project milestones on time and within budget. Author relevant sections in regulatory filings and address agency questions Provide analytical support for process optimization, scale-up, tech transfer, and process characterization activities for both drug substance and drug product. Collaborate with Quality Control to set product release and stability/shelf-life specifications Participate in selection and evaluation of CROs and CDMOs. Support Manufacturing and Quality in deviation investigations and product life cycle management. Support Translational Research and Business Development as a technical consultant. Follow all safety and compliance regulations and company policies at work. Requirements: A degree in Chemistry or a related discipline. PhD with minimum 5 years’ relevant working experience, or MS with minimum 12 years, or BS with minimum 15 years. Must have hands-on experience in analytical method development for small molecules drug substances and drug products. Method qualification and validation experience is a plus. Must have extensive knowledge and hands-on experience with analytical techniques including HPLC, LCMS, GC, GCMS, UV/Vis, and Dissolution. Experience of impurity identification in both Drug Substance and Drug Product is a plus. Knowledgeable in ICP-MS/IPC-OES, DSC, DVS and XRPD techniques are a plus. Working knowledge of quality and regulatory requirements of small molecule products including cGMP/GLP, FDA, USP, Ph. Eur, and ICH guidelines Experience working with CDMO/CRO to lead analytical method development, method transfer, method qualification/validation is preferred. Excellent problem-solving skills and verbal and written communication skills. Experience in both early and late stage CMC development is desired. #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.

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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: talentacquisition@ultragenyx.com.