Manufacturing Associate II / III, Purification (Days)

Biogen; North Carolina; On-site; USD 32,000 - 47,000; Full time

Benefits offered by this job

Medical, Dental, Vision insurance

401(k) with company match

Paid time off and holiday pay

Job summary

Biogen is seeking Manufacturing Associates for our Drug Substance facility in Research Triangle Park, NC. Roles involve downstream purification and column chromatography, viral filtration, and ultrafiltration on a 2-2-3 night shift calendar.

Responsibilities include operating process equipment, documenting cGMP data, and maintaining a clean, audit-ready environment. Positions emphasize training, teamwork, and commitment to delivering therapies.

Qualifications

• Bachelor’s degree in STEM or equivalent
• BioWorks Certificate or associate’s degree preferred
• GxP environment experience
• Aseptic/cleanroom experience preferred
• Process automation understanding with DeltaV/LIMS familiarity

Responsibilities

• Operate process equipment and execute validation protocols per cGMP SOPs
• Document and record cGMP data and deviations
• Create and revise batch records, SLRs and equipment logbooks
• Assist in in-process sampling and analysis (pH, Conductivity, Protein Concentration, Osmolarity)
• Maintain a clean and audit-ready work environment
• Lead training initiatives and mentor team members

Skills

GxP experience

SOP adherence

aseptic/cleanroom

DeltaV/LIMS

Process automation

Pipetting

Education

B.S./B.A. in STEM

BioWorks Certificate

Associate's degree

High School Diploma

Tools

DeltaV

LIMS

Job description

About This RoleOur factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation.Shift Details: This role follows a 2-2-3 calendar rotation on nights (6:00 AM – 6:00 PM ET)Internal Shift Details: Black Days rotating scheduleOur Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations – each playing a critical role in delivering our therapies to the patients who need them.Our teams are organized by the steps in the biomanufacturing process that they operate in; including – Upstream (Cell Culture), Downstream (Purification), and Media & Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP).This role’s primary focus is Downstream (Purification):Column ChromatographyViral FiltrationUltra-FiltrationBulk Dispensing of the drug substanceWhat You’ll DoExecute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating Procedures (SOPs)Document and record all cGMP data & information (including deviations) for processing steps and equipment activitiesCreate and revise key documentation like batch records, SLRs, and equipment logbooksAssist in conducting in-process sampling and sampling analysis (pH, Conductivity, Protein Concentration, Osmolarity, etc.)Help maintain a clean and safe work environment, always focusing on audit readiness of process areasBe a team player and leader; always showing up to contribute your energy and focusActively participate and lead in training and development initiatives, both for personal growth and for that of your team membersWho You AreYou’re driven by a mission to save lives and bring a deep sense of purpose to the work you do. Biomanufacturing is complex, and you thrive in fast-paced environments where learning agility, problem-solving, and adaptability are essential.Required Skills for a Manufacturing Associate II: $23.56 - $30.77 Pay RangeThe following combination of academic and/or relevant experience may be considered:Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 0+ years of direct experienceA BioWorks Certificate or associate's degree, STEM preferred and at minimum 0+ year of direct experienceA High School Diploma (or equivalent) and at minimum of .5 years of direct experiencePrevious experience in a GxP environmentAbility to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP) Understanding of working in an aseptic or cleanroom environment is preferredUnderstanding of process automation and software systems (e.g. DeltaV, LIMS, etc.)Required Skills for a Manufacturing Associate III: $25.96 - $34.13 Pay RangeThe following combination of academic and/or relevant experience may be considered:Bachelor’s degree from an accredited college or university, STEM preferred and at minimum .5 years of direct experienceA BioWorks Certificate or associate's degree, STEM preferred and at minimum 1 year of direct experienceA High School Diploma (or equivalent) and at minimum of 1.5 years of direct experiencePrevious experience in a cGMP environmentDemonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP)Experience or understanding of working in an aseptic or cleanroom environmentUnderstanding of process automation and software systems (e.g. DeltaV, LIMS, etc.)Previous pipetting experience in a laboratory or manufacturing environment is preferredJob Level: Entry LevelAdditional InformationThe base compensation range for this role is: $23.56-$34.14Base 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.