Gene Therapy Upstream Manufacturing Lead (12h Shifts)

Ultragenyx Pharmaceutical; Bedford; On-site; GBP 121,000 - 149,000; Full time

Benefits offered by this job

Vacation time and holidays

Volunteer days

Employee stock purchase plans

Wellbeing benefits

Fitness reimbursement

Tuition sponsoring

Professional development plans

Job summary

Ultragenyx Pharmaceutical seeks an experienced Upstream Manufacturing Manager to lead a 5-person shift in a 12-hour rotating schedule, focusing on cell culture operations from vial thaw to 2K viral particle production.

The role requires 10+ years in leadership within Biologics, strong collaboration, and a proven track record in a 24/7 GMP environment. On-site work with growth opportunities and safety emphasis.

Qualifications

• Ideally, degree in Engineering or Scientific Discipline, equivalent education/experience could be considered.
• Ability to be on call for Upstream MFG alarms off shift.
• 10+ years leadership positions with direct reports ideally in Biologics environment running 24/7.
• Experience with GMP manufacturing of viral vectors and/or biological processes.
• Strong collaboration, team-working skills, and communication skills.

Responsibilities

• Act as Area Lead for audits and regulatory inspections.
• Drive the manufacturing review of the completed batch records per the release plan.
• Driver of all assigned quality system items (Deviations, CAPA, Change Control), SOPs, MBRs, Risk Assessments etc.
• Demonstrate ownership of the process to ensure resources are available.
• Identify Continuous Improvements to the process/equipment and drive projects to completion.
• Ensure Business System Ownership (BSO) ownership of equipment and facility.

Skills

Leadership

GMP manufacturing

Biologics

Communication

Teamwork

Education

Engineering degree

Job description

Ultragenyx Pharmaceutical seeks an experienced Upstream Manufacturing Manager to lead a 5-person shift in a 12-hour rotating schedule, focusing on cell culture operations from vial thaw to 2K viral particle production.

The role requires 10+ years in leadership within Biologics, strong collaboration, and a proven track record in a 24/7 GMP environment. On-site work with growth opportunities and safety emphasis.