Senior Manager, Drug Substance Manufacturing Upstream

The role

The Upstream Manufacturing Manager will supervise a shift of 5 manufacturing technicians and Associates. The role focuses on cell culture operations from vial thaw through to 2K operations for the production of viral particles for gene therapy products.

What you will do

• Act as Area Lead for internal/external Audits and host tours
• Front room SME presenting for regulatory inspections
• Drive manufacturing review of completed batch records
• Drive assigned quality system items including Deviations, CAPA, Change Control, SOPs, MBRs, and Risk Assessments
• Ensure availability of materials, personnel, and documentation for processing
• Identify and drive Continuous Improvements to process and equipment
• Demonstrate Business System Ownership of equipment and facility
• Provide oversight and responsibility for technicians including compliance, training, safety and career development
• Serve as project lead on higher level initiatives
• Ensure robust communications between manufacturing managers and support staff

Required qualifications

• 10+ years leadership positions with direct reports
• Experience with GMP manufacturing of viral vectors and/or biological processes
• Strong collaboration, team-working skills, and communication skills
• Ability to be on call for Upstream MFG alarms off shift
• Stand for extended periods of time with periodic stooping / bending / kneeling
• Able to lift, push, pull up to 50lbs
• Climb ladders and stairs of various heights
• Work in a controlled environment requiring GxP gowning and protective clothing
• Ability to change clothes into appropriate gowning and personal protective equipment
• Medical clearance required for use of a respirator
• Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment
• Working in temperature-controlled environments (cold rooms)

Nice to have

• degree in Engineering or Scientific Discipline

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

About the company

Ultragenyx Pharmaceutical aims to lead the future of rare disease medicine by following science and using a novel rapid development approach. The company focuses on creating a supportive and inclusive environment for its employees.