Manufacturing Associate IV / V, Small Scale Purification (Days)

Biogen, Inc.; North Carolina; On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness reimburse.

Disability insurance (short/long-term)

Paid vacation & holidays

Job summary

Biogen, Inc. in Research Triangle Park, NC is hiring Manufacturing Associates for downstream purification in a cGMP environment.

Roles involve 12-hour day/night shifts on a 2-2-3 calendar, working in a cleanroom and supporting chromatography, viral filtration and ultrafiltration processes. Candidates should have a STEM background with 2+ years direct experience (or an equivalent certificate), knowledge of SOPs and GDP, and experience with process automation tools.

Qualifications

• Bachelor's degree, STEM preferred and at least 2 years direct experience.
• BioWorks Certificate or associate's degree, STEM preferred and at least 2.5 years direct experience.
• High School Diploma with at least 3 years direct experience.

Responsibilities

• Execute daily manufacturing activities and operate process equipment per cGMP SOPs.
• Document cGMP data, deviations, batch records, and equipment logs.
• Assist in sampling and analysis (pH, conductivity, protein concentration, osmolarity).
• Maintain clean, audit-ready process areas and participate in training and development.

Skills

cGMP knowledge

SOP adherence

GDP documentation

Pipetting in lab/manufacturing

Process automation (DeltaV/LIMS)

Aseptic/cleanroom experience

Education

Bachelor’s degree, STEM preferred

BioWorks certificate or associate degree

High School Diploma + 3 years experience

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 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.

Who You Are

You are 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
• Exposure to single use consumables 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
• Exposure to single use consumables preferred

Job Level: Entry Level

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.

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. 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.

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.