Associate Director, Biologics Manufacturing Management

Ultragenyx Pharmaceutical•Bedford, MA

5d•Hybrid

About The Position

This role provides 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. The Associate Director will serve as an external manufacturing relationship manager at respective contract manufacturing organizations (CMOs) and represent manufacturing as part of cross-functional Ultragenyx CMC teams. The work model is Flex, typically requiring onsite work 2-3 days each week, or more depending on business needs. Some locations may have specific days designated for onsite work.

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. Fewer years are acceptable if combined with relevant advanced degree.
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.
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) and occasional person-in-plant activities.

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.