Senior Engineer, Aseptic Drug Manufacturing & Tech Transfer

Biogen; Asheville (NC); On-site; USD 98,000 - 149,000; Full time

Job summary

Biogen seeks a Senior Engineer in Manufacturing Sciences to support aseptic drug product manufacturing at its Research Triangle Park facility. The role combines technical expertise in sterile processes with cross-functional collaboration to enable commercial production and continuous improvement of biopharmaceutical products.

Responsibilities include providing technical expertise in aseptic filling, sterile filtration, formulation, and related drug product processes, designing experiments,

Qualifications

• Bachelor's degree in relevant scientific or technical field.
• 4+ years (Sr. I) or 6+ years (Sr. II) directly relevant industry experience.
• Familiarity with pharmaceutical or biopharmaceutical manufacturing, preferably sterile/aseptic operations.
• Experience designing experiments, analyzing process data, and executing laboratory studies.
• Understanding of GMP requirements and aseptic manufacturing principles.
• Willingness to work on-site during training, critical projects, audits, and validation activities.

Responsibilities

• Provide technical expertise in aseptic filling, sterile filtration, formulation, and related drug product processes.
• Design, execute, and document studies to improve process robustness and troubleshoot manufacturing issues.
• Lead or support technology transfers of drug products into GMP manufacturing.
• Serve as technical subject matter expert for manufacturing investigations and CAPA implementation.
• Support process validation activities including media fills, PPQ campaigns, and technical reporting.

Skills

Aseptic manufacturing processes

Process optimization

Experiment design

Cross-functional collaboration

Education

Bachelor's degree

Job description

Biogen seeks a Senior Engineer in Manufacturing Sciences to support aseptic drug product manufacturing at its Research Triangle Park facility. The role combines technical expertise in sterile processes with cross-functional collaboration to enable commercial production and continuous improvement of biopharmaceutical products.

Responsibilities include providing technical expertise in aseptic filling, sterile filtration, formulation, and related drug product processes, designing experiments,