Engineer III, Manufacturing Sciences - Cell Culture

Biogen

North Carolina

On-site

USD 81,000 - 105,000

Full time

2 days ago
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Job summary

Biogen is seeking an Engineer in Manufacturing Sciences to support cell culture bioprocessing for drug substance at the RTP facility. You will execute laboratory studies, analyze samples, and provide SME input on up­stream transfers and CAPAs, collaborating across Technical Development, Engineering, and GMP Manufacturing.

The role emphasizes hands-on problem solving, data-driven process improvement, and on-site work during training and audits.

Qualifications

  • Bachelor’s degree in relevant scientific or technical field from an accredited college or university.
  • At least 2 years of directly relevant industry experience.
  • Familiarity with biopharmaceutical manufacturing or mammalian cell culture.
  • Willingness to work on-site during training periods, critical projects, audits, etc., including rotating weekend work.
  • Experience executing laboratory studies, performing biochemical testing of samples, and analyzing data.

Responsibilities

  • Provide technical expertise in mammalian cell culture and bioreactor operations to support tech transfer and process improvement.
  • Plan, execute, and document laboratory studies to improve process robustness and understanding.
  • Collaborate with Technical Development, Engineering, and GMP Manufacturing on cross-functional teams.
  • Support upstream GMP operations, including process transfer activities and ongoing campaigns.
  • Serve as technical SME for investigations, contributing to root cause analysis and CAPA implementation.
  • Represent manufacturing sciences in change controls, CI initiatives, and regulatory documentation.
  • Support process validation activities, including batch execution and technical reports.
  • Analyze manufacturing data and communicate insights to stakeholders.

Skills

Mammalian cell culture
Data analysis
Laboratory studies
Regulatory documentation
Change controls/CAPAs

Education

Bachelor's degree in engineering or life science
Bachelor’s degree in relevant field

Job description

About This RoleAn Engineer in Manufacturing Sciences serves as a key scientific resource supporting cell culture bioprocessing for drug substance manufacturing at Biogen’s RTP facility. This role enables successful production of biopharmaceuticals by executing laboratory studies and sample analysis, assisting upstream process transfers into GMP manufacturing, and providing scientific input on ongoing commercial operations.What You’ll DoProvide technical expertise in mammalian cell culture and bioreactor operations to support technology transfer and process improvement initiativesPlan, execute, and document laboratory studies under moderate supervision to improve process robustness, enhance process understanding, and troubleshoot manufacturing issuesCollaborate with Technical Development, Engineering, and GMP Manufacturing on cross-functional project teamsSupport upstream GMP operations, including process transfer activities, ongoing manufacturing campaigns, and laboratory analysis of samples from manufacturingServe as technical SME for investigations, contributing to root cause analysis and implementation of effective corrective and preventive actions (CAPAs)Represent manufacturing sciences in change controls, continuous improvement initiatives, capital projects, and new component introductionsSupport process validation activities, including batch execution and authoring technical summary reportsAnalyze manufacturing data and experimental results, clearly communicating insights and recommendations to stakeholdersWho You AreYou are a hands-on, scientifically driven problem solver with experience in mammalian cell culture. You thrive in collaborative environments, enjoy proactive ownership of laboratory operations, and are motivated to improve manufacturing processes through practical, data-driven solutions.Required SkillsBachelor’s degree in relevant scientific or technical fields from an accredited college or universityAt minimum 2 years of directly relevant industry or industry-adjacent experienceFamiliarity with biopharmaceutical manufacturing or mammalian cell culturePrevious experience with some or all of the following: execute laboratory studies, perform biochemical testing of samples, and/or analyze dataWillingness and ability to work on-site more frequently during training periods, critical projects, audits, etc., and rotating weekend workPreferred skillsBachelor’s degree in engineering or life sciencePrior experience acting as a technical SME within a manufacturing support organizationDemonstrated experience leading scientific studies related to cell cultureExperience supporting deviations, technical assessments, change controls, CAPAs, and regulatory documentationJob Level: ProfessionalAdditional InformationThe base compensation range for this role is: $81,000.00-$105,000.00Base 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 insurancesFitness & Wellness programs including a fitness reimbursementShort- and Long-Term Disability insuranceA 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 Significance80 hours of sick time per calendar yearPaid Maternity and Parental Leave benefit401(k) program participation with company matched contributionsEmployee stock purchase planTuition reimbursement of up to $10,000 per calendar yearEmployee Resource Groups participationWhy 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. Read on to learn more about our Biogen.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.
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