Bioprocess Associate IV: Upstream/Downstream ASO

Biogen, Inc.; Northern (KY); Hybrid; USD 89,544,000 - 117,096,000; Full time

Benefits offered by this job

Medical Insurance

Tuition reimbursement

Paid vacation and holidays

401(k) matching

Job summary

Biogen is seeking a Manufacturing Associate IV to join the Drug Product facility in RTP. The role focuses on upstream and downstream ASO manufacturing, operating process equipment, and executing validation protocols in a cGMP environment.

You will document cGMP data, update batch records, and participate in training to support continuous improvement and audit readiness. This is an entry-level to mid-level manufacturing position with steady schedule expectations.

Qualifications

• Bachelor’s degree in STEM with 2+ years of direct experience.
• BioWorks certificate or associate’s degree with 2.5+ years of direct experience.
• High school diploma with 3+ years of direct experience.
• Experience in a cGMP environment and good documentation practices.
• Ability to follow SOPs and understand GDP.
• Understanding process automation and software systems like LIMS.

Responsibilities

• Execute daily manufacturing activities including operating process equipment and executing validation protocols per cGMP SOPs.
• Monitor critical upstream processes and troubleshoot equipment issues.
• Perform upstream and downstream ASO manufacturing operations in a cGMP setting.
• Document all cGMP data and deviations for steps and equipment activities.
• Create and update batch records, SLRs, and equipment logbooks.
• Conduct in-process sampling and analyses (e.g., pH, Osmolarity).
• Maintain a clean, audit-ready work environment.
• Participate in training and development for self and team.

Skills

Bachelor’s degree in STEM with 2+ yrs

BioWorks Certificate or associate's in

High School Diploma with 3+ yrs exp

cGMP environment experience

Follow SOPs & GDP

Process automation & LIMS familiarity

Education

Bachelor’s degree in STEM

BioWorks Certificate or associate's degree

High School Diploma or equivalent

Tools

LIMS

Job description

Biogen is seeking a Manufacturing Associate IV to join the Drug Product facility in RTP. The role focuses on upstream and downstream ASO manufacturing, operating process equipment, and executing validation protocols in a cGMP environment.

You will document cGMP data, update batch records, and participate in training to support continuous improvement and audit readiness. This is an entry-level to mid-level manufacturing position with steady schedule expectations.