Associate Director, Biologics Manufacturing Management - Remote

Overview

This position involves providing technical expertise for critical starting materials, drug substance, and/or drug product manufacturing for Ultragenyx's biologics portfolio, serving as the external manufacturing relationship manager at contract manufacturing organizations.

In Short

• Oversee external manufacturing of biologics drug substances and products.
• Support Biologics CMC strategy and milestones.
• Ensure fulfillment of manufacturing services at CMOs.
• Author global CMC filings in compliance with regulations.
• Identify and select DS and DP CMOs.
• Manage relationships with CMOs and partnerships.
• Handle purchase orders, invoices, and contracts.
• Participate in Health Authority interactions.
• Manage product or manufacturing process risks.
• Support contract negotiations with CMOs.

Requirements

• BS in Pharmaceutical, Biological or Bioengineering Sciences.
• 10+ years of experience in Process Development or Manufacturing in biotech/pharmaceutical.
• Technical experience in commercial bioprocess manufacturing.
• Experience with CMO/CDMO management.
• Cross-functional experience in Quality Assurance and Regulatory Affairs.
• Proficient in cGMPs and pharmaceutical regulations.
• Strong project management and communication skills.
• Ability to work across multiple time zones.
• Up to 25% travel commitments.

Benefits

• Generous vacation time and public holidays.
• Volunteer days.
• Long-term incentive and employee stock purchase plans.
• Employee wellbeing benefits.
• Fitness reimbursement.
• Tuition sponsoring.
• Professional development plans.