Associate Director, Biologics Manufacturing Management

Summary

Join Ultragenyx, a biopharmaceutical company focused on rare disease treatments, and become a key member of our biologics CMC team. You will provide technical expertise for manufacturing processes, manage relationships with contract manufacturing organizations (CMOs), and contribute to global CMC filings. This remote position requires extensive experience in bioprocess manufacturing, CMC, and project management. You will play a crucial role in ensuring the successful development and commercialization of our biologic products. The role offers a competitive salary, comprehensive benefits, and opportunities for professional growth within a supportive and inclusive environment. We are committed to making a meaningful impact on the lives of our patients and employees.

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 launch and commercial bioprocess manufacturing, including one or more of upstream drug substance, downstream drug substance, or drug product manufacturing
• Strong collaboration, communication skills and drive for results
• Experienced in both late-stage development and manufacturing/launching of complex biologic modalities such as Monoclonal Antibodies, Enzymes or RNA based medicines
• Experience in CMC and product development teams
• Strong Project management skills
• Excellent problem-solving skills and verbal/written communication skills
• Proficient in cGMPs and pharmaceutical industry procedures and regulations
• Good understanding of financial figures, cost management and financial decision making
• Passionate about helping patients and collaboratively working in a diverse environment
• Substantial experience working in an outsourcing model, involving CMO/CDMO management with up to 25% travel commitments (domestic and international) and occasional person-in-plant activities
• Ability to support work requirements across multiple time zones and reflective of 24/7 manufacturing schedules at CMO sites, as applicable

Responsibilities

• 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

Preferred Qualifications

Cross-functional experience in Quality Assurance, Regulatory Affairs, R&D are desirable

Benefits

• Generous vacation time and public holidays observed by the company
• Volunteer days
• Long term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• Professional development plans
• Annual bonus and equity incentives