Engineer III, Manufacturing Sciences

Biogen seeks an Engineer III, Manufacturing Sciences to serve as a technical expert on single-use consumable raw materials across biopharmaceutical manufacturing. The role involves managing extractables and leachables programs, conducting supplier assessments, and supporting process optimization initiatives globally from Research Triangle Park, NC.

Responsibilities

• Serve as technical point of contact for single-use consumable raw materials across global manufacturing network
• Develop and implement raw material control strategies and monitoring technologies for material release
• Lead continuous improvement initiatives and support new item requests and supplier audits
• Conduct investigations including laboratory experiments, root cause analyses, and material failure troubleshooting
• Perform technical risk assessments for vendor changes and new items, including extractables/leachables impact evaluations

Requirements

• Bachelor's degree in scientific or technical field from accredited institution
• Minimum 2 years directly relevant industry or industry-adjacent experience
• Knowledge of polymeric materials, chemistry, and single-use systems
• Experience supporting deviations, change controls, CAPAs, and regulatory documentation
• Willingness to work on-site frequently during training, audits, and critical projects
• Preferred: extractables and leachables study experience and regulatory knowledge
• Preferred: familiarity with container closure systems and supplier change management

Compensation: $81,000-$105,000 base