Manufacturing Associate III / IV, Purification (Nights)

Biogen, Inc.; Northern (KY); Hybrid; USD 36,000 - 56,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness reimbursement

Paid vacation and year-end shutdown

Job summary

Biogen is seeking a Manufacturing Associate III/IV for Night shifts in Research Triangle Park, NC. You will perform downstream purification tasks, operate chromatography, viral filtration, and ultrafiltration steps in a cGMP cleanroom.

The role emphasizes documentation, batch records, and in-process sampling while ensuring audit readiness and contributing to a high-performing team on a 2-2-3 night rotation.

Qualifications

• Requires a Bachelor’s degree in a STEM field or equivalent.
• BioWorks certificate or associate’s degree with relevant experience considered.
• High School Diploma with sufficient direct experience also acceptable.
• Experience in a cGMP environment and GDP documentation practices required.

Responsibilities

• Execute daily manufacturing activities, operating process equipment per cGMP SOPs.
• Document and record cGMP data and deviations for steps and equipment.
• Create/revise batch records, SLRs, and equipment logbooks.
• Assist in in-process sampling and analysis (pH, Conductivity, protein, osmolarity).
• Maintain clean, safe work environment and audit readiness.
• Participate in training and development of self and team members.

Skills

Bachelor’s degree in STEM

BioWorks Certificate

Associate’s degree

High School Diploma

Experience in cGMP environment

SOP compliance

GDP documentation

Aseptic/cleanroom experience

Process automation knowledge (DeltaV,L

Pipetting experience

Education

Bachelor’s degree in STEM

BioWorks Certificate

Associate’s degree

High School Diploma

Tools

DeltaV

LIMS

Job description

## Manufacturing Associate III / IV, Purification (Nights)Apply: On Campus: Research Triangle Park, NC: Full time: Posted Today: REQ24156**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:** Red 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 III:** $25.96 - $34.13 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 .5 years of direct experience + A BioWorks Certificate or associate's degree, STEM preferred and at minimum 1 year of direct experience + A High School Diploma (or equivalent) and at minimum of 1.5 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 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 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.Job Level: Entry Level**Additional Information**The base compensation range for this role is: $25.96-$40.87Base 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