Senior Engineer I/II, Manufacturing Sciences – Drug Product

About This Role

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.

What You’ll Do

• 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

Who You Are

You are a hands-on, scientifically driven problem solver with experience supporting sterile pharmaceutical manufacturing operations. You enjoy collaborating across functions, investigating complex technical challenges, and leveraging data to improve process performance, product quality, and manufacturing reliability.

Sr. Engineer I - Required Skills (Salary Range: $98,000.00 - $127,000.00)

• 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

• Advanced degrees may be considered as relevant experience

• 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

Sr. Engineer II - Required Skills (Salary Range: $111,000.00 - $149,000.00)

• Bachelor’s degree in relevant scientific or technical fields from an accredited college or university
• At minimum 6 years of directly relevant industry or industry-adjacent experience

• Advanced degrees may be considered as relevant experience

• 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

Preferred skills

• 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

Job Level: Professional

Additional Information

The base compensation range for this role is: $98,000.00-$127,250.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and…