Associate Director Biologics Manufacturing Management

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 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 crossfunctional Ultragenyx CMC teams.

Work Model:

Flex: This role will typically require onsite work 23 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.

Or

Remote: Officially documented as working fulltime from home with travel to Ultragenyxs offices or other locations on occasion as needed.

Responsibilities:

• Oversee external manufacturing of biologics drug substance manufacturing and aseptic drug product manufacturing for biologics and oligonucleotides.
• Support Biologics 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.
• Ensure fulfillment of agreed manufacturing services at CMOs for clinical and commercial supply plans.
• 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.
• Lead relationships with CMOs and foster collaborative partnership.
• Own relevant purchase orders invoices and contracts to support external expense activities.
• Participate in Health Authority interactions as a subject matter expert.
• Actively identify and manage product or manufacturing process risks.
• Support 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 approve purchase orders & invoices and improve COGS development.

Requirements:

• BS in Pharmaceutical 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 launchand commercial bioprocess manufacturing including one or more of plasmid DNA upstream drug substance downstream drug substance or drug product manufacturing.
• Substantial experience working in an outsourcing model involving CMO/CDMO management.
• Experienced in both latestage development and manufacturing/launching of complex biologic modalities such as Plasmid DNA Monoclonal Antibodies Enzymes or RNA based medicines.
• Experience in CMC and product development teams.
• Crossfunctional 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.
• Strong Project management skills.
• Strong collaboration communication skills and drive for results.
• Excellent problemsolving skills and verbal/written communication skills.
• Passionate about helping patients and collaboratively working in a diverse environment.
• Ability to support work requirements across multiple time zones and reflective of 24/7 manufacturing schedules at CMO sites as applicable.
• Up to 25 travel commitments (domestic and international) and occasional personinplant activities.

Physical Demand Requirements:

• Stand for extended periods of time with periodic stooping / bending / kneeling
• Able to lift push pull up to 50lbs.
• Work in a controlled environment requiring GxP gowning and wear protective clothing over the head face hands feet and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment.
• Must remove all makeup jewelry and contact lenses while in the manufacturing environment. #LICS1#LIHybrid