Senior Engineer I/II, Manufacturing Sciences – Drug Product

Biogen • Research Triangle Park, NC

1d • $98,000 - $149,000 • Onsite

About The Position

The Senior Engineer I/II, Manufacturing Sciences serves as a key scientific and technical resource supporting aseptic drug product manufacturing at Biogen’s RTP Pharma facility. This role enables the successful production of sterile biopharmaceutical products by providing expertise in aseptic filling processes, supporting technology transfers, leading process improvement initiatives, and partnering closely with GMP manufacturing to ensure reliable commercial operations.

Requirements

• Bachelor’s degree in relevant scientific or technical fields from an accredited college or university
• At minimum 4 years of directly relevant industry or industry-adjacent experience (for Sr. Engineer I)
• At minimum 6 years of directly relevant industry or industry-adjacent experience (for Sr. Engineer II)
• Familiarity with pharmaceutical or biopharmaceutical manufacturing, preferably within sterile or aseptic drug product operations
• Experience designing experiments, analyzing process data, executing laboratory studies, and/or supporting manufacturing investigations
• Understanding of GMP requirements and aseptic manufacturing principles
• Willingness and ability to work on-site more frequently during training periods, critical projects, audits, validation activities, and manufacturing support needs

Nice To Haves

• Demonstrated experience supporting aseptic filling, sterile filtration, formulation, or other drug product manufacturing processes
• Experience with Process Validation, aseptic process simulations (media fills), and sterile manufacturing best practices
• Previous experience leading complex scientific or technical projects within a GMP manufacturing environment
• Experience performing root cause analysis and risk-based technical assessments
• Experience supporting deviations, change controls, CAPAs, CPV, and regulatory documentation
• Prior experience acting as a technical lead or SME within a manufacturing support organization
• Advanced degrees may be considered as relevant experience

Responsibilities

• Provide technical expertise in aseptic drug product manufacturing, including formulation, sterile filtration, aseptic filling, visual inspection, and associated drug product processes
• Design, plan, execute, and document laboratory and manufacturing support studies to improve process robustness, enhance process understanding, and troubleshoot manufacturing issues
• Lead or support drug product technology transfers into GMP manufacturing
• Partner cross-functionally with Technical Development, Engineering, Quality, Validation, and Manufacturing Operations to support commercial production and continuous improvement efforts
• Serve as a technical SME for manufacturing investigations, performing root cause analyses and implementing effective corrective and preventive actions (CAPAs)
• Support aseptic processing initiatives, including process monitoring, contamination control strategies, and operational excellence activities
• Represent Manufacturing Sciences in change controls, continuous improvement efforts, capital projects, equipment implementation, and new component introductions
• Support process validation activities, including media fills, PPQ campaigns, batch execution support, and authoring technical summary reports
• Analyze manufacturing data and experimental results, communicating clear technical conclusions and recommendations to stakeholders

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation
• Cash bonus
• Equity incentive opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level