Associate Director, Biologics Manufacturing Management

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

You will provide technical expertise for critical starting materials, drug substance, and/or drug product manufacturing over the life cycle of the products in the Ultragenyx biologics/gene therapy portfolio from development through commercialization. You will serve as external manufacturing relationship manager at the respective contract manufacturing organizations (CMOs) and represent manufacturing as part of cross-functional Ultragenyx CMC teams.  

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:

1. Oversee external manufacturing of plasmid DNA, biologics and gene therapy drug substance, as well as aseptic drug product manufacturing for biologics and oligonucleotides. 
2. Ensure fulfillment of agreed manufacturing services at CMOs for clinical and commercial supply plans. 
3. Lead relationships with CMOs and foster collaborative partnership. 
4. Participate in Health Authority interactions as a subject matter expert. 
5. Author global CMC filings in accordance with applicable regulations and guidance.   
6. Identify and enable selection of DS and DP CMOs, ensure CMO compliance to cGMPs and establish strategic fit. 
7. Actively identify and manage product or manufacturing process risks. 
8. Manage process optimization, tech transfer, and change control. 
9. Drive troubleshooting and quality deviation investigations occurring at manufacturing sites. 
10. Direct key business agreements, manage budget & cost control, approve purchase orders & invoices, and improve COGS development. 

Requirements:

1. BS in Pharmaceutical, Biological or Bioengineering Sciences or Engineering. 
2. 10+ years of relevant combined experience in Process Development, MSAT, Quality Assurance, or Manufacturing in biotech / pharmaceutical industry. Fewer years are acceptable if combined with relevant advanced degree. 
3. Technical experience in process development and commercial bioprocess manufacturing, including one or more of plasmid DNA, enzymes, antibodies, gene therapies, or aseptic drug product manufacturing.  
4. Substantial experience working in an outsourcing model, involving CMO/CDMO management. 
5. Proficient in cGMPs and pharmaceutical industry procedures and regulations. 
6. Good understanding of financial figures, cost management and financial decision making. 
7. Strong collaboration