Manufacturing Associate IV / V, Purification (Nights)

Biogen, Inc.; Northern (KY); Hybrid; USD 43,000 - 61,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness Reimbursement

Disability Insurance

Paid Vacation

Job summary

Biogen is hiring a Manufacturing Associate IV/V for nights at the Research Triangle Park site. The role emphasizes downstream purification with chromatography, viral filtration, and ultrafiltration in a cleanroom environment.

You will document data, revise batch records, and support in-process sampling while maintaining audit-ready areas. The position requires a STEM degree or equivalent experience, cGMP exposure, and proficiency with SOPs.

Qualifications

• Experience in a cGMP environment and following SOPs.
• Good documentation practices and record-keeping.
• Experience in aseptic/cleanroom settings and pipetting.

Responsibilities

• Operate process equipment and follow SOPs to execute manufacturing steps.
• Record cGMP data and deviations; maintain batch records and logs.
• Assist in sampling, analysis, and equipment housekeeping.
• Support training and development of team members.

Skills

cGMP

SOPs

GDP

Aseptic

DeltaV

LIMS

Pipetting

Documentation

Education

Bachelor's degree (STEM)

BioWorks certificate or associate's

High School Diploma with experience

Tools

DeltaV

LIMS

Job description

## Manufacturing Associate IV / V, Purification (Nights)Apply: On Campus: Research Triangle Park, NC: Full time: Posted Yesterday: REQ24136**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 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 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 environmentJob Level: Professional**Additional Information**The base compensation range for this role is: $31.25-$43.27Base 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.