Associate Director, Biologics Manufacturing Management

Position Summary

At Ultragenyx, you will have the opportunity to tackle rare and dynamic challenges as a technical expert for critical starting materials, drug substance, and/or drug product manufacturing. You will serve as an external manufacturing relationship manager at contract manufacturing organizations (CMOs) and represent manufacturing as part of cross-functional Ultragenyx CMC teams.

Responsibilities

• Oversee external manufacturing of plasmid DNA, biologics and gene therapy drug substance, as well as aseptic drug product manufacturing for biologics and oligonucleotides.
• Ensure fulfillment of agreed manufacturing services at CMOs for clinical and commercial supply plans.
• Lead relationships with CMOs and foster collaborative partnerships.
• Participate in Health Authority interactions as a subject matter expert.
• Author global CMC filings in accordance with applicable regulations and guidance.
• Identify and enable selection of DS and DP CMOs, ensure CMO compliance to cGMPs and establish strategic fit.
• Actively identify and manage product or manufacturing process risks.
• 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, approve purchase orders & invoices, and improve COGS development.

Requirements

• BS in Pharmaceutical, Biological or Bioengineering Sciences or Engineering.
• 10+ years of relevant combined experience in Process Development, MSAT, Quality Assurance, or Manufacturing in biotech / pharmaceutical industry.
• Substantial experience working in an outsourcing model, involving CMO/CDMO management.
• Proficient in cGMPs and pharmaceutical industry procedures and regulations.
• Good understanding of financial figures, cost management and financial decision making.
• Strong collaboration, communication skills and drive for results.
• Excellent problem-solving skills and verbal/written communication skills.
• Ability to support work requirements across multiple Ultragenyx time zones and reflective of 24/7 manufacturing schedules at CMO sites, as applicable.
• Up to 25% travel commitments (domestic and international).