Manufacturing Associate IV / V, Purification (Days)

Biogen; Milwaukee (WI); On-site; USD 42,705 - 59,236; Full time

Benefits offered by this job

Medical benefits

Dental & Vision

401(k) matching

Tuition reimbursement

Stock purchase plan

Paid time off

Parental leave

Job summary

Biogen is hiring Manufacturing Associates to support downstream purification in a cGMP environment at our facility. This role involves 12-hour day/night shifts on a 2-2-3 calendar, with focus on chromatography, viral filtration, ultrafiltration, and bulk drug substance handling.

The position requires a bachelor’s or equivalent in STEM or related field (or a related certificate) with relevant experience; demonstrated SOP/GDP compliance and aseptic/cleanroom exposure are essential.

Qualifications

• Bachelor’s degree in STEM or related field with at least 2 years direct experience.
• BioWorks Certificate or associate's degree with at least 2.5 years direct experience.
• High School Diploma (or equivalent) with at least 3 years direct experience.
• Experience in a cGMP environment.
• Ability to follow SOPs and GDP.
• Experience working in aseptic/cleanroom environments.
• Understanding of process automation and software systems (DeltaV, LIMS).
• Pipetting experience in lab/manufacturing environments.

Responsibilities

• Execute daily manufacturing activities, operating process equipment and adhering to cGMP SOPs.
• Document and record cGMP data and deviations for processing steps and equipment activities.
• Create and revise batch records, SLRs, and equipment logbooks.
• Assist in in-process sampling and analysis (pH, Conductivity, Protein Concentration, Osmolarity).
• Maintain a clean, safe work environment and audit readiness of process areas.
• Collaborate with team members and contribute energy and focus.
• Participate in and lead training and development initiatives.

Skills

cGMP experience

SOPs & GDP

Aseptic/cleanroom

Process automation (DeltaV, LIMS)

Pipetting in lab/manufacturing

Team leadership

Education

Bachelor’s degree in STEM or related

BioWorks Certificate or associate's degree

High School Diploma with ≥3 years direct experience

Tools

DeltaV

LIMS

TrackWise

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.

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 days (6:00 AM – 6:00 PM ET)

Internal Shift Details:

Red Days 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

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 years 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 or understanding of 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 year 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 preferred.
• Problem solving, troubleshooting, and EBR experience preferred.
• CMMS and TrackWise experience preferred.

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

• 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.