Senior Manager/Associate Director, Manufacturing Management, Biologics and mRNA

Novato, CA, Brisbane, CA or US Remote

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Ultragenyx

Ultragenyx is leading the future of rare disease medicine. We are committed in moving the rare disease community forward.

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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. During the COVID-19 pandemic, we are committed to the health and safety of our employees and prospective employees, which means at this time our interview processes may include virtual discussions, interviews, and onboarding. Please note that compliance with local regulations and safety protocols is a condition of employment at Ultragenyx. Elements of safety protocols may include, but are not limited to: work from home requirements, regular or symptom-based covid testing, providing valid evidence of vaccination, mask wearing, and physical distancing. US based roles: Full vaccination against COVID-19 is a condition of employment at Ultragenyx. This requirement applies to almost all roles at Ultragenyx based in the U.S., with very limited exceptions. If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.   Roles based outside the US:  If the role requires travel to the US or another country that requires evidence of covid vaccination for entry, candidates and employees will be required follow the local regulations and corporate policy regarding vaccination evidence submission.

Position Summary:  ultracurious – Apply your biggest ideas in courageous ways  
You will support development, launch and commercialization of Ultragenyx Biologics and mRNA products. You will serve as contract manufacturing organization (CMO) relationship manager and team member of various projects in the CMC area representing Manufacturing. You will provide manufacturing science and technology (MSAT) expertise for product manufacturing over the lifecycle of the products and help build the manufacturing team for our Biologics and mRNA portfolio. You will work with Technical Development, Translational Science, Quality, Supply Chain Management, Regulatory, Commercial, and Business Development organizations within the company and a variety of CMOs. You will report to the Executive Director,Biologics and mRNA Manufacturing Management.  
This role is based out of either the Novato or Brisbane, CA locations, but may be considered for remote employment. 
Work Model:
This is a Flex role, which 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
Remote: officially documented as working full time from home, with travel to Ultragenyx's offices or other location on occasion as needed

Responsibilities:

  • Lead or participate in CMC initiatives for Ultragenyx´s Biologics and mRNA portfolio for both Drug Substance and Drug Product manufacturing of clinical and commercial programs 
  • Support Biologics and mRNA CMC strategy, milestones, and goals with input from key stakeholders 
  • Develop and maintain various program files such as the CMC Project Plan, QTPP (Quality Target Product Profile), and Quality Risk Management Plan 
  • Ensure fulfillment of agreed manufacturing service for clinical and commercial supply 
  • Author global CMC regulatory filings in accordance with applicable regulations and guidance  
  • Identify and drive selection ofDS and DP CMOs, and establish strategic fit 
  • Lead relationships with CMOs and foster collaborative partnership 
  • Participate in Health Authority interactions as a subject matter expert 
  • Actively identify and manage product or manufacturing process risks 
  • Drive contract negotiation with CMOs to ensure sustainable supply and partnership 
  • Manage process optimization, tech transfer, and change control 
  • Drive troubleshooting and quality deviation investigations occurring at manufacturing sites 
  • Direct key business agreements, manage budget & cost control and improve COGS development 

Requirements:

  • BS in Pharmaceutical, Chemical, Biological or Bioengineering Sciences or Engineering 
  • 10+ years of relevant experience in Process Development, MSAT or Manufacturing in biotech / pharmaceutical industry. Fewer years are acceptable if combined with relevant advanced degree 
  • Technical experience in launch and commercial manufacturing (incl. drug substance upstream, downstream, and/or aseptic drug product) of Biotech products, ideally for rare diseases. Subject matter expertise in mammalian/bacterial culture unit operations is highly desirable 
  • Strong collaboration, communication skills, and drive for results 
  • Experienced in both late-stage development and manufacturing/launching of complex biologic modalities such as Monoclonal Antibodies, Enzymes, or RNA based medicines 
  • Experience in CMC and product development teams 
  • Strong project management skills 
  • Substantial experience working in an outsourcing model, CMO/CDMO management with up to 20% travel commitments and working in a highly matrixed organization 
  • Excellent problem-solving skills and verbal/written communication skills 
  • Cross-functional experience in Quality Assurance, Regulatory Affairs, R&D are desirable 
  • Proficient in cGMPs and pharmaceutical industry procedures and regulations 
  • Good understanding of financial figures, cost management and financial decision making 
  • Passionate about helping patients and collaboratively working in a diverse environment 
#LI-CZ1#LI-REMOTE #REMOTE
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 & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.com. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information. 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.

Tags: Compliance Cross-functional Human Resources Manufacturing Project management R&D Recruiting Risk management Subject matter expert Supply Chain Talent acquisition

Perks/benefits: Career development Fitness / gym Flex vacation Health care Travel

Regions: Asia/Pacific North America
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