Senior Engineer I/II, Manufacturing Sciences – Drug Product

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

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 company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well‑being; including, but not limited to:

• 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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid‑sized biotechnology company, we provide the stability and resources of a well‑established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life‑changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.

Biogen is an E-Verify Employer in the United States.

As Biogen recently acquired Apellis, you can find additional open jobs on our Apellis website here.