Downstream Purification Specialist — Night Shift (12h)

Biogen, Inc.; North Carolina; Vor Ort; USD 43.000 - 60.000; Vollzeit

Benefits dieser Stelle

Medical, Dental, Vision

401(k) with company match

Tuition reimbursement

Paid time off

Zusammenfassung

Biogen, Inc. is seeking a Manufacturing Associate IV at our Drug Substance facility in Research Triangle Park, NC.

This role operates on a 2-2-3 calendar rotation on nights (6:00 PM – 6:00 AM ET) in a 24/7 manufacturing setting, focusing on Downstream (Purification) steps including column chromatography and viral filtration. You will execute daily manufacturing activities, document cGMP data, and contribute to training while maintaining a clean, audit-ready environment.

Qualifikationen

• Bachelor’s degree in STEM with direct experience in a cGMP environment.
• BioWorks Certificate or associate's degree with direct experience in biomanufacturing.
• High School Diploma or equivalent with direct experience in a manufacturing setting.

Aufgaben

• Execute daily manufacturing activities, operating process equipment and following SOPs.
• Document and record cGMP data and deviations for steps and equipment.
• Create and revise batch records, SLRs, and equipment logbooks.
• Assist in in-process sampling and analysis (pH, Conductivity, Protein concentration).
• Maintain a clean, audit-ready environment in process areas.
• Contribute to training and development within the team.

Kenntnisse

cGMP experience

SOP adherence

Aseptic environment

DeltaV/LIMS knowledge

Pipetting

Documentation practices

Ausbildung

Bachelor's degree in STEM

BioWorks Certificate or associate's degree

High School Diploma

Tools

DeltaV

LIMS

Jobbeschreibung

Biogen, Inc. is seeking a Manufacturing Associate IV at our Drug Substance facility in Research Triangle Park, NC.

This role operates on a 2-2-3 calendar rotation on nights (6:00 PM – 6:00 AM ET) in a 24/7 manufacturing setting, focusing on Downstream (Purification) steps including column chromatography and viral filtration. You will execute daily manufacturing activities, document cGMP data, and contribute to training while maintaining a clean, audit-ready environment.