Upstream Drug Substance Manufacturing Lead

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

Benefits offered by this job

Generous vacation time and public holi

Long term incentive

Employee stock purchase plans

Fitness reimbursement

Job summary

Ultragenyx is seeking a Senior Manager, Drug Substance Manufacturing Upstream in Bedford, MA. The role leads a shift of technicians on a 12-hour schedule focused on cell culture from vial thaw to 2K viral particle production for gene therapy products.

On-site work is typical, with leadership responsibilities and compliance oversight. Requirements include a degree in engineering or sciences, 10+ years in leadership, and experience with GMP manufacturing of viral vectors.

Qualifications

• Degree in Engineering or Scientific Discipline or equivalent experience.
• Experience leading teams in biologics or viral vector manufacturing environments.
• Strong collaboration and communication skills across functions.

Responsibilities

• Act as Area Lead for internal/external audits and site tours.
• Lead regulatory inspection readiness and host inspections.
• Drive batch release reviews per the release plan.
• Own quality system items (Deviations, CAPA, Change Control) and SOP MBRS.
• Ensure resources (materials, personnel, documentation) are available for processing.
• Champion continuous improvement projects for processes/equipment.
• Ensure ownership of equipment and facility by the Business System.

Skills

Leadership

GMP manufacturing

Biologics

Regulatory inspections

Education

Engineering or scientific discipline

Job description

Ultragenyx is seeking a Senior Manager, Drug Substance Manufacturing Upstream in Bedford, MA. The role leads a shift of technicians on a 12-hour schedule focused on cell culture from vial thaw to 2K viral particle production for gene therapy products.

On-site work is typical, with leadership responsibilities and compliance oversight. Requirements include a degree in engineering or sciences, 10+ years in leadership, and experience with GMP manufacturing of viral vectors.