Director, Manufacturing Management, Biologics and mRNA

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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 Outbreak, we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our approach will include video discussions, interviews, and onboarding.

Position Summary

ultracurious – Apply your biggest ideas in courageous ways

You will drive late stage development, launch and commercialization of Ultragenyx Biologics and mRNA products. You will provide technical expertise for product manufacturing over the life cycle of the products and help build the manufacturing team for our Biologics and mRNA portfolio. You will serve as CMO relationship manager and team member of various projects in the CMC area representing Manufacturing. 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 can be based REMOTE on the East Coast, USA or in our European Head Offices near Basel, Switzerland.

You Will

• Lead projects for the Biologics and mRNA team within Manufacturing Management
• Lead CMC projects of Ultragenyx´s Biologics and mRNA portfolio
• Drive and support Biologics and mRNA CMC strategy, milestones and goals with input from the key stakeholders, such as the CMC Review Forum and gaining approval from the Program Core Team and the respective functional management
• Develop and maintain CMC Project Plan, QTPP (Quality Target Product Profile), Product Design History File and Quality Risk Management Plan
• Ensure fulfillment of agreed manufacturing service for clinical and commercial supply
• Author global CMC filings in accordance with applicable regulations and guidance
• Identify and select API and DP CMOs, ensure CMO compliance to cGMPs and establish strategic fit
• Lead relationships with CMOs and foster collaborative partnership
• Lead and / or 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
• Represent Manufacturing Management in Operational Excellence initiatives within Tech Ops and CMC
• Drive performance management and continuous improvement
• Develop and nurture high performance teams
• Provide strong representation on global projects, CMC initiatives and product core teams
• Support Ultragenyx projects and support synergy between Biologic and mRNA programs and Gene Therapy programs
• Support manufacturing activities for the Gene Therapy manufacturing group (as needed)
  

You Have

• Degree in Pharmaceutical, Biological or Bioengineering Sciences or Engineering
• BS degree with 15+ years or MS/PhD with 10+ years of relevant experience in Process Development, MSAT or Manufacturing in biotech / pharmaceutical industry.
• Technical experience in launch and commercial manufacturing (incl. upstream, downstream, and/or fill & finish) 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 25% 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
  

Applications and CV’s to be submitted in English. Eligible applicants are in possession of a valid work permit.

#Remote

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 .

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 .