Manufacturing Associate IV / V, Purification (Nights)

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness Reimbursement

Short-Term Disability

Long-Term Disability

Vacation 15+ days + shutdown

Paid Holidays

Sick time 80 hours/year

Maternity/Parental Leave

401(k) Matching

Employee Stock Purchase Plan

Tuition Reimbursement

Employee Resource Groups

Job summary

Biogen in RTP, NC is hiring Manufacturing Associates focused on Downstream (Purification) operations within a 2-2-3 calendar on nights (6:00 PM – 6:00 AM ET). Roles involve chromatography, viral filtration, and ultra-filtration in a cGMP cleanroom.

Responsibilities include executing daily manufacturing activities, documenting data, preparing batch records, and leading training initiatives. Requires STEM background with relevant experience and strong SOP/GDP adherence.

Qualifications

• Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 2 years of direct experience.
• 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

Responsibilities

• Execute daily manufacturing activities, operating process equipment and following cGMP SOPs.
• Document and record all cGMP data 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 and safe work environment with audit readiness of process areas.
• Be a team player and contribute energy and focus.
• Lead training and development initiatives for self and team.

Skills

cGMP environment

SOPs & GDP

aseptic/cleanroom

Process automation (DeltaV, LIMS)

Pipetting in manufacturing

Education

Bachelor’s in STEM + 2+ years

BioWorks Certificate / Associate’s + 2.5+ years

HS 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.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’s 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.