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

The Senior Manager of Material Science within Manufacturing Sciences and Technology (MSAT) is responsible for supporting MSAT materials activities for tech transfer, process validation, and routine GMP manufacturing. You will serve as the subject matter expert for single-use technologies (SUT) and raw materials (RM) with in-depth knowledge of industry best practices and regulatory guidelines of viral vector production for internal and external contract manufacturing facilities.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

• Lead the Assessment of new materials, and implement best practices in SUT and RM across multiple programs, including a phase-appropriate program and control strategy based on scientific and risk principles
• Compile vendor source documents and author technical and risk assessment documents to support SUT and RM onboarding, including authoring functional risk assessments and component design reviews for SUT, and technical assessments for alternative new and alternative chemical assessments
• Lead external lab studies for extractable and leachable along with the risk assessments
• Support identification and control of material attributes for GMP operation of drug substances, drug products and ancillary devices.
• Support supplier notification/deviation/investigation and change controls as a material SME in a fast-paced GMP facility
• Support QC raw material risk assessment and help to identify material to be used for testing as needed
• Be familiar with container closure integrity (CCIT) and support CCIT testing for drug substance and drug product
• Partner with Manufacturing, Supply Chain, and Quality teams to address material improvements and alternate sourcing opportunities
• Author technical documents and regulatory submissions

Requirements:

• BS/M.S/Ph.D in Material Science, Chemical Engineering, Bioengineering or Polymer Science. B.S with 8+ or MS with 6+ or Ph.D with 2+ years of relevant experience working in Pharmaceutical Manufacturing or Contract Manufacturing
• ≥ 3 years direct experience in SUT, filters, chromatography resins, excipients, and primary packaging and/or secondary packaging. Including prior experience working on consumable and single-use assessments
• Solid understanding of cGMP compliance and regulatory agency requirements for raw materials and SUT.
• Solid knowledge of chemical raw material standards (USP, compendia, BPOG, etc.)
• Strong understanding of polymers and chemicals, their function in bioprocesses, and their impact on cells and viral vectors.
• Knowledge in extractable and leachable, CCIT, raw material risk assessment
• Demonstrated problem-solving ability in a fast-paced environment.
• Strong communication and technical writing skills
• Strong collaboration and team-building, communication, and organizational skills required
• Experience working with and managing third-party contractors and vendors is a plus
• Experience owning, managing, and executing records using a quality management system (Veeva) is a plus
• Travel Requirements 10% estimate #LI-CS1 #LI-Onsite

  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.

See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy.   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.PDN-9d4fa69f-c31d-4050-8380-35fc1ef735ec