Senior Aseptic Manufacturing Scientist: Process Transfer

Biogen, Inc.; North Carolina; On-site; USD 98,000 - 149,000; Full time

Benefits offered by this job

Medical insurance

Dental plan

Vision plan

401(k) match

Paid time off

Job summary

Biogen, Inc. in RTP, North Carolina is seeking a Senior Engineer I/II, Manufacturing Sciences to serve as a technical resource for aseptic drug product manufacturing.

You will lead process improvements, support technology transfers, and partner with GMP manufacturing to ensure reliable commercial operations. The role requires hands-on, data-driven problem solving across sterile filling, filtration, and related processes, with on-site work during training and critical projects.

Qualifications

• Bachelor’s degree in relevant scientific or technical field; advanced degrees may be considered.
• Experience in sterile/aseptic drug product operations is preferred.
• Familiarity with GMP requirements and aseptic manufacturing principles.

Responsibilities

• Provide technical expertise in aseptic drug product manufacturing including formulation, sterile filtration, aseptic filling, and visual inspection.
• Design and execute laboratory and manufacturing support studies to improve process robustness and troubleshoot issues.
• Lead or support drug product technology transfers into GMP manufacturing.
• Collaborate with Technical Development, Engineering, Quality, Validation, and Manufacturing Operations for product quality and continuous improvement.
• Perform root cause analyses and implement CAPAs for manufacturing investigations and deviations.
• Support process validation activities including media fills and PPQ campaigns.

Skills

Aseptic manufacturing

GMP knowledge

Experimental design

Process data analysis

Root cause analysis

CAPAs

Cross-functional collaboration

Technical documentation

Education

Bachelor’s degree in relevant scientific or technical field

Advanced degrees may be considered

Job description

Biogen, Inc. in RTP, North Carolina is seeking a Senior Engineer I/II, Manufacturing Sciences to serve as a technical resource for aseptic drug product manufacturing.

You will lead process improvements, support technology transfers, and partner with GMP manufacturing to ensure reliable commercial operations. The role requires hands-on, data-driven problem solving across sterile filling, filtration, and related processes, with on-site work during training and critical projects.