Senior Upstream Biologics Manufacturing Lead

Ultragenyx Pharmaceutical; Bedford (MA); On-site; USD 160,000 - 197,000; Full time

Benefits offered by this job

Generous vacation time and public holl

Volunteer days

Employee stock purchase plans or alike

Employee wellbeing benefits

Fitness reimbursement

Tuition sponsoring

Professional development plans

Job summary

Ultragenyx Pharmaceutical in Massachusetts is seeking an Upstream Manufacturing Manager to oversee a shift of five manufacturing technicians on a 12-hour rotating schedule, focusing on cell culture operations from vial thaw to 2K viral particle production for gene therapy products. The role reports to the Sr.

Director of Upstream Manufacturing and requires on-site work with quality systems ownership, audit readiness, and collaboration across a matrix environment to drive continuous improvements

Qualifications

• Degree in Engineering or Scientific Discipline; relevant education/experience.
• On-call for upstream MFG alarms off shift.
• 10+ years leadership with direct reports ideally in Biologics environment running 24/7.
• Experience with GMP manufacturing of viral vectors and/or biological processes.

Responsibilities

• Act as Area Lead for internal/external audits as required, including hosting tours.
• Front room SME presenting for 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.
• Own the process resources to ensure that all resources required for processing are available.
• Identify any Continuous Improvements to the process/equipment and drive through to completion any projects.
• Ensure Business System Ownership (BSO) ownership of the equipment and facility is demonstrated at all times.
• Lead technicians and ensure training, safety and career development within Ultragenyx.

Skills

Leadership

Teamwork

Communication

Education

Degree in Engineering or Scientific Discipline

Job description

Ultragenyx Pharmaceutical in Massachusetts is seeking an Upstream Manufacturing Manager to oversee a shift of five manufacturing technicians on a 12-hour rotating schedule, focusing on cell culture operations from vial thaw to 2K viral particle production for gene therapy products. The role reports to the Sr.

Director of Upstream Manufacturing and requires on-site work with quality systems ownership, audit readiness, and collaboration across a matrix environment to drive continuous improvements