Manufacturing Associate IV / V, Purification (Nights)

Biogen; Milwaukee (WI); On-site; USD 43,000 - 59,000; Full time

Benefits offered by this job

Health insurance

401(k) match

Tuition reimbursement

Paid time off

Job summary

Biogen is seeking Manufacturing Associates to operate in a cGMP, aseptic cleanroom setting within our Drug Substance facility. The role emphasizes downstream purification and daily production tasks, documentation, and team collaboration to ensure quality and patient safety.

Roles require strong SOP/GDP discipline, relevant education in STEM or related certificates, and experience with DeltaV/LIMS systems. Competitive pay and comprehensive benefits accompany the position.

Qualifications

• Bachelor’s degree in STEM with 2+ years direct experience or equivalent
• BioWorks Certificate or an associate’s degree with 2.5+ years direct experience
• High School Diploma with 3+ years direct experience in a cGMP environment
• Experience following SOPs and GDP in a regulated setting
• Aseptic/cleanroom experience and familiarity with lab/manufacturing instrumentation

Responsibilities

• Execute daily manufacturing activities and operate process equipment per cGMP SOPs
• Document cGMP data and deviations for processing steps and equipment activities
• Create and revise batch records, logs and equipment documentation
• Assist in in-process sampling and analysis (pH, Conductivity, Protein)
• Maintain a clean, safe work environment and audit readiness of process areas
• Participate in training and lead development initiatives for team members

Skills

cGMP experience

SOP adherence

GDP knowledge

aseptic/cleanroom

process automation

pipetting

Education

Bachelor’s degree, STEM

BioWorks Certificate / associate's degree

High School Diploma + 3 years

Tools

DeltaV

LIMS

Job description

About This Role

Our 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 PM – 6:00 AM ET)

Internal Shift Details

Black Nights rotating schedule

Our 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 Chromatography
• Viral Filtration
• Ultra-Filtration
• Bulk Dispensing of the drug substance

What You’ll Do

• Execute 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 activities
• Create and revise key documentation like batch records, SLRs, and equipment logbooks
• Assist 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 areas
• Be a team player and leader; always showing up to contribute your energy and focus
• Actively participate and lead in training and development initiatives, both for personal growth and for that of your team members

Who You Are

You’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 IV:

$31.25 - $40.87 Pay Range

• The 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 2 years of direct experience
  • A BioWorks Certificate or associate's degree, STEM preferred and at minimum 2.5 year of direct experience
  • A High School Diploma (or equivalent) and at minimum of 3 years of direct experience
• Previous experience in a cGMP environment
• Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP)
• Experience working in an aseptic or cleanroom environment
• Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.)
• Previous pipetting experience in a laboratory or manufacturing environment preferred

Required Skills for a Manufacturing Associate V:

$33.17 - $43.27 Pay Range

• The 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 4 years of direct experience
  • A BioWorks Certificate or associate's degree, STEM preferred and at minimum 4.5 years of direct experience
  • A High School Diploma (or equivalent) and at minimum of 5 years of direct experience
• Previous experience in a cGMP environment
• Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP)
• Experience working in an aseptic or cleanroom environment
• Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.)
• Previous pipetting experience in a laboratory or manufacturing environment

Job Level: Professional

Additional Information

The base compensation range for this role is: $31.25-$43.27

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.

Benefits

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, 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. 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.