Engineer III, Manufacturing Sciences

Biogen, Inc.; North Carolina; Hybrid; USD 81,000 - 105,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness Reimbursement

Disability Insurance

Paid Vacation and year-end shutdown

Paid Holidays

Sick Time

Maternity and Parental Leave

401(k) with company match

Employee stock purchase plan

Tuition Reimbursement

Employee Resource Groups

Job summary

Biogen is seeking an Engineer III, Manufacturing Sciences to provide technical leadership across end-to-end single-use consumable raw materials from Drug Substance through Drug Product fill. Hybrid role with on-site inspections and audits.

You will lead extractables/leachables program assessments, support material control strategies, and collaborate with suppliers, sites, and regulators to ensure compliant and fit-for-use materials for current and future manufacturing needs.

Qualifications

• Bachelor’s degree in scientific/technical field from an accredited college or university.
• At least 2 years of directly relevant industry experience.
• Knowledge of polymeric materials, chemistry, and single-use systems for biopharmaceutical manufacturing.
• Experience supporting deviations, change controls, CAPAs, and regulatory documentation.
• Willingness and ability to work on-site more frequently during training periods, critical projects, audits, etc.

Responsibilities

• Serve as technical POC for single-use consumable raw materials, supplier capabilities, control strategies, and manufacturing needs across the global network.
• Support development and implementation of raw material control strategies and monitoring technologies for incoming material release.
• Lead continuous improvement initiatives related to raw materials including support for new item requests and supplier audits.
• Conduct investigations by performing lab experiments, gathering supplier data, developing historical trends, and assessing lot usage.
• Troubleshoot single-use material failures (e.g., filter integrity test failures), perform root cause analyses, and evaluate potential process impacts.
• Perform technical risk assessments for Vendor Change Notifications (VCNs) and New Item Requests (NIRs), including chemical compatibility and stability assessments.
• Own and support global extractables/leachables studies, aligning with current global regulatory guidance.
• Participate in industry forums and external E/L collaborations to advance best practices.
• Support internal and agency inspections, vendor audits, and regulatory filings related to raw materials and single-use technologies.

Skills

Single-use materials expertise

Deviation/ CAPA support

Regulatory documentation experience

Anti-leachables knowledge

On-site training availability

Education

Bachelor’s degree in relevant field

Preferred: engineering/chemistry/materials science

Job description

About this role

The Engineer III, Manufacturing Sciences is a key technical contributor providing expertise across end-to-end single-use consumable raw materials, from Drug Substance through Drug Product fill. This role supports the Process Optimization & Technology (PO&T) organization by assessing raw material changes, deviations, CAPAs, and regulatory documentation, while serving as the expert of extractables and leachables (E/L) program assessments. The position partners closely with suppliers, manufacturing sites, and regulatory teams to ensure materials are fit for use, compliant with evolving global regulations, and capable of supporting both current and future manufacturing needs. This is a hybrid role with on-site presence required during inspections and vendor audits.

What you’ll do

• Serve as a technical POC for single-use consumable raw materials, supplier capabilities, control strategies, and manufacturing needs across the global manufacturing network
• Support development and implementation of raw material control strategies and monitoring technologies to enable incoming material release
• Lead continuous improvement initiatives related to raw materials, including technical support for new item requests and supplier audits
• Conduct investigations by performing laboratory experiments, gathering supplier data, developing historical trends, and assessing lot usage
• Troubleshoot single-use material failures (e.g., filter integrity test failures), perform root cause analyses, and evaluate potential process impacts
• Perform technical risk assessments for Vendor Change Notifications (VCNs) and New Item Requests (NIRs), including chemical compatibility, stability, thermal properties, and extractables/leachables impact
• Own and support global extractables/leachables studies, ensuring alignment with current global regulatory guidance
• Participate in industry forums and external E/L collaborations to advance best practices
• Support internal and agency inspections, vendor audits, and regulatory filings related to raw materials and single-use technologies

Who you are

You are a technically curious and analytical engineer who enjoys solving complex manufacturing challenges and collaborating across functions. You work independently, proactively identify improvements, and are comfortable serving as a technical leader within your area of expertise.

Required skills

• Bachelor’s degree in relevant scientific or technical fields from an accredited college or university
• At minimum 2 years of directly relevant industry or industry-adjacent experience
• Knowledge of polymeric materials, chemistry, and single-use systems for biopharmaceutical manufacturing
• Experience supporting deviations, change controls, CAPAs, and regulatory documentation
• Willingness and ability to work on-site more frequently during training periods, critical projects, audits, etc.

Preferred skills

• Bachelor’s degree in engineering, chemistry, materials science, or a related technical field from an accredited college or university
• Hands-on experience with extractables and leachables studies and regulatory expectations
• Familiarity with single-use systems, container closure systems, and supplier change management
• Prior technical experience within a manufacturing or engineering organization
• Previous experience partnering with external contractors and vendors

Job Level

Professional

Additional Information

The base compensation range for this role is: $81,000.00-$105,000.00. 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.

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.