Manufacturing Readiness Lead, Tech Transfer & Projects

Biogen; North Carolina; On-site; USD 85,000 - 115,000; Full time

Job summary

Biogen in North Carolina is seeking a Sr. Manufacturing Specialist I to support ASO, OSD, and L&P teams with manufacturing readiness, process implementation, and technical writing during technology transfer and startup activities.

The role requires detail orientation, strong technical writing, and project-management skills, with weekday core hours and occasional off-hours support as needed to ensure successful product transfers and regulatory-compliant documentation.

Qualifications

• Bachelor's degree required; direct experience may substitute.
• 3+ years in biotech/pharma or adjacent field.
• Experience in biopharmaceutical environments with cGMP knowledge.
• Experience authoring, reviewing, and maintaining technical documentation.
• Intermediate to advanced Microsoft Office and quality systems experience.
• Experience in Continuous Improvement, Operational Excellence, Manufacturing Excellence, or Process Improvement programs.

Responsibilities

• Lead site readiness plans for product transfer and process technology.
• Coordinate change controls, documentation readiness, and training readiness.
• Lead readiness reviews, governance meetings, and stakeholder communications.
• Identify readiness gaps and escalate issues as needed.
• Lead complex cross-functional projects supporting technology transfer and manufacturing improvements.
• Author and maintain manufacturing documentation with a high degree of accuracy and compliance.

Skills

Root cause analysis

Technical documentation

Microsoft Office

Continuous improvement

Project management

Education

Bachelor's degree in biotech/pharma or related field

Job description

Biogen in North Carolina is seeking a Sr. Manufacturing Specialist I to support ASO, OSD, and L&P teams with manufacturing readiness, process implementation, and technical writing during technology transfer and startup activities.

The role requires detail orientation, strong technical writing, and project-management skills, with weekday core hours and occasional off-hours support as needed to ensure successful product transfers and regulatory-compliant documentation.