Manufacturing Readiness & Tech Transfer Lead

Biogen, Inc.; Northern (KY); Hybrid; USD 98,000 - 127,000; Full time

Benefits offered by this job

Medical, dental, vision, & life insur

Fitness & wellness programs

Paid vacation and holidays

401(k) with company match

Tuition reimbursement

Employee stock purchase plan

Job summary

Biogen, Inc. is seeking a Sr. Manufacturing Specialist I to support ASO, OSD, and L&P teams with technical writing, project management, and process implementation.

The role emphasizes attention to detail, structured problem-solving, and cross-functional collaboration in a fast-paced biotech setting. The position involves leading complex readiness activities, coordinating change controls and documentation, and driving continuous improvement across manufacturing startup activities.

Qualifications

• Minimum 3 years direct biotech/pharma experience.
• Experience authoring and maintaining manufacturing documentation and records.
• Strong knowledge of cGMP regulations and quality systems.

Responsibilities

• Serve as primary receiving-site operational readiness lead for product and process transfers.
• Develop and drive site readiness plans aligning startup activities across functions.
• Lead readiness reviews, governance meetings, action tracking, and stakeholder communications.
• Own change controls, CAPAs, and continuous improvement initiatives.
• Author and maintain manufacturing documentation with high accuracy and compliance.
• Lead or support investigations and root-cause analyses using structured problem-solving.

Skills

Technical writing

Project management

Continuous improvement

Root cause analysis

Cross-functional collaboration

Microsoft Office

GMP knowledge

Manufacturing operations

Education

Bachelor's degree

Tools

Documentation software

Computer-based quality systems

Job description

Biogen, Inc. is seeking a Sr. Manufacturing Specialist I to support ASO, OSD, and L&P teams with technical writing, project management, and process implementation.

The role emphasizes attention to detail, structured problem-solving, and cross-functional collaboration in a fast-paced biotech setting. The position involves leading complex readiness activities, coordinating change controls and documentation, and driving continuous improvement across manufacturing startup activities.