Senior Director, Manufacturing Sciences and Technology (MSAT)

Why Join Us?   Be a hero for our rare disease patients   At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.    Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.   If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

The Senior Director, Manufacturing Sciences and Technology will oversee the Drug Substance (DS) team, providing technical and program leadership for early- and late-phase AAV manufacturing processes at both internal and contract manufacturing facilities.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

 

Responsibilities:

• Establish and improve systems and procedures for Technology Transfer, Process Performance Qualification (PPQ) and Continued Process Verification (CPV) of AAV gene therapy programs.
• Lead a team to deliver technology transfers for the early and late phase AAV manufacturing processes at both internal and contract manufacturing facilities. Own process control strategy documents, facility fit, process change assessment, FMEA, tech transfer plan, campaign summary reports, investigation reports and other technical and risk assessment documents.
• Lead the DS PPQ teams, own process validation master plans, DS PPQ master plans, PPQ protocols and PPQ reports.
• Lead the CPV program, own CPV plans, interim reports and Annual Product Reviews (APRs) for commercial products. Lead cross-functional manufacturing data review meetings. Develop and drive lifecycle management of commercial products.
• Lead a CMC team or represent MSAT and manufacturing functions in a CMC team. Provide technical and strategic leadership to drive alignment of critical decisions and risk mitigations within CMC functions and ensure timely delivery of CMC milestones per established contract. 
• Leverage process expertise and Operational Excellence approaches to lead / support process/operational deviations and manufacturing investigations, provide product impact assessment or risk assessment, support root cause identifications and Corrective Action and Preventive Actions (CAPA).
• Stay current with the AAV manufacturing technology innovation, and drive implementation of process improvements targeted at reducing manufacturing costs and improving process yield/product quality throughout the lifecycle of the product.
• Author module 3 section of regulatory submissions (IND/IMPD/BLA/MAA) and respond to information requests by health authorities.
• Lead the tracking, execution, and close-out of process-related post-marketing regulatory commitments; represent MSAT in Change Review meetings.
• Manage and mentor junior MSAT team members.

Requirements:

• Ph.D. or master’s degree in science or equivalent with substantial experience in pharmaceutical industry
• 12+ years in life sciences industry. Biologics, Gene / Cell Therapy experience required
• Experience with IND and BLA regulatory authoring
• Advanced manufacturing and technical acumen in the early, late and commercial phases of biopharmaceutical development and manufacturing
• Understanding of relevant global regulation and phase appropriate GxP requirements
• Experience with regulatory inspections and writing investigations and product impact summaries that meet regulatory expectations
• Excellent verbal and written communication skills
• Ability to work independently and as part of a team
• Experienced in working in a matrix organization with ability to influence and drive decision-making with