Job Description

ultrafocused – Work together to fearlessly uncover new possibilities

Reporting to the Senior Director of Downstream Centrals Services Manufacturing at Ultragenyx, the Senior Manager will lead, build, and motivate the internal Downstream Central Services manufacturing group for our AAV gene therapy products. Experience in solution preparation, sterilization of equipment in a cleanroom environment, and downstream processes following approved cGMP documentation is required. This role will work collaboratively with the Senior Director Drug Substance Downstream Central Services to ensure all gene therapy programs are supplied with high quality product in a safe, timely and cost-effective manner. This role will have responsibility for the planning, coordination, and start-up/commercial manufacturing of our internal manufacturing facility and delivery of product to clinical sites/patients and commercial supply for our AAV gene therapy products.

The person will collaborate closely with Bulk Drug Manufacturing, Drug Product Manufacturing, Pharmaceutical Development, Quality Assurance, Quality Control, and Program teams to deliver strong technical evaluations and appropriate solutions to challenging supply problems. The incumbent actively drives synergies between the various technical modality's groups across the globe. This individual will support all products from pre-clinical programs through commercial stage products. The candidate has a demonstrated ability to build and manage a team to achieve consistently positive results.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site. This is a shift based position from 6am to 4.30pm Wednesday through Saturday.

Responsibilities:

• Build and manage team members in their day-to-day work
• Create an environment that supports rewarding career growth and development
• Lead/actively support and encourage cross functional collaborative work environment
• Act as the primary contact to ensure effective collaborations with relevant internal departments (Upstream and Process Development, Analytical Development, MSAT,Engineering, Validation, QA, QC, Regulatory Affairs, and Program Management).
• Ensure phase-appropriate manufacturing, with an appreciation of late-stage manufacturing including process characterization and process validation activities.
• Collaborate closely with MSAT and Process Development to ensure efficient technical transfer of manufacturing processes to the Manufacturing facility.
• Ensure supply of high-quality gene therapy products by providing oversight through batch record review, deviation assessment, batch disposition and supply chain
  oversight.
• Partner with Quality functions (QA/QC, Qualified Persons, and CMO Quality organizations) to ensure timely and appropriate batch disposition.
• Review / endorse / sponsor cross-functional CMC initiatives and execution plans
• Review, and/or approve Standard Operating Procedures, specifications, regulatory filing,or other controlled documents as needed
• Develop and monitor department goals, objectives, and metrics
• Implement and evaluate continuous improvement opportunities
• Monitor international trends in technology, manufacturing, quality and supply;represent the interest of Ultragenyx in various forums
• Live the company values by example including Ultragenyx´s Quality mindset principles
• Apply manufacturing concepts, tools and practices while driving to define how they are applied in the novel and growing field of gene therapy.

Requirements:

• Build and manage team members in their day-to-day work
• Create an environment that supports rewarding career growth and development
• Lead/actively support and encourage cross functional collaborative work environment
• Act as the primary contact to ensure effective collaborations with relevant internal departments (Upstream and downstream Process Development, Analytical Development, MSAT, Engineering, Validation, QA, QC, Regulatory Affairs, and Program Management).
• Ensure phase-appropriate manufacturing, with an appreciation of late-stage manufacturing including process characterization and process validation activities.
• Collaborate closely with MSAT and Process Development to ensure efficient technical transfer of manufacturing processes to the Manufacturing facility.
• Ensure supply of high-quality gene therapy products by providing oversight through batch record review, deviation assessment, batch disposition and supply chain oversight.
• Partner with Quality functions (QA/QC, Qualified Persons, and CMO Quality organizations) to ensure timely and appropriate batch disposition.
• Review / endorse / sponsor cross-functional CMC initiatives and execution plans
• Review, and/or approve Standard Operating Procedures, specifications, regulatory filing,or other controlled documents as needed
• Develop and monitor department goals, objectives, and metrics
• Implement and evaluate continuous improvement opportunities
• Monitor international trends in technology, manufacturing, quality and supply;represent the interest of Ultragenyx in various forums
• Live the company values by example including Ultragenyx´s Quality mindset principles
• Apply manufacturing concepts, tools and practices while driving to define how they are applied in the novel and growing field of gene therapy.

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