Manufacturing Associate IV, OSM/OPM (ASO) (Days)
Biogen
August 21, 2026
On-site
Triangle, NC
Operations
Shift Details:
- Monday–Thursday 6 am–4 pm
- Occasional need for Friday and after-hours support
What You’ll Do:
- Execute daily cGMP manufacturing activities: operate process equipment and perform validation protocols per SOPs
- Perform/monitor upstream processes; troubleshoot operational and equipment issues
- Execute upstream and downstream ASO manufacturing in a cGMP environment; follow batch records, SOPs, and production schedules
- Document and record cGMP data (including deviations); create/revise batch records, SLRs, and equipment logbooks
- Perform in-process sampling and analysis (e.g., pH, Osmolarity)
- Maintain a clean, safe, audit-ready work environment
- Participate in training and development
Required Skills / Qualifications (Manufacturing Associate IV):
- Bachelor’s (STEM preferred) + at least 2 years direct experience, OR BioWorks certificate/associate’s (STEM preferred) + 2.5 years, OR High School (or equivalent) + 3 years
- Previous cGMP experience
- Ability to follow SOPs and adhere to Good Documentation Practices (GDP)
- Understanding of process automation and software systems (e.g., LIMS)
Physical Requirements:
- Climb ladders, work in tight spaces, lift/move equipment up to 50 lbs
- Comfortable in cleanroom with gowning; stand up to 3 hours
Compensation/Benefits:
- Pay range: $31.25–$40.87
- Medical, dental, vision, life insurance; fitness/wellness reimbursement; short-/long-term disability; paid vacation (min 15 days) + end-of-year shutdown; paid holidays; sick time; maternity/parental leave; 401(k) with match; employee stock purchase plan; tuition reimbursement (up to $10,000/year); employee resource groups participation
- Monday–Thursday 6 am–4 pm
- Occasional need for Friday and after-hours support
What You’ll Do:
- Execute daily cGMP manufacturing activities: operate process equipment and perform validation protocols per SOPs
- Perform/monitor upstream processes; troubleshoot operational and equipment issues
- Execute upstream and downstream ASO manufacturing in a cGMP environment; follow batch records, SOPs, and production schedules
- Document and record cGMP data (including deviations); create/revise batch records, SLRs, and equipment logbooks
- Perform in-process sampling and analysis (e.g., pH, Osmolarity)
- Maintain a clean, safe, audit-ready work environment
- Participate in training and development
Required Skills / Qualifications (Manufacturing Associate IV):
- Bachelor’s (STEM preferred) + at least 2 years direct experience, OR BioWorks certificate/associate’s (STEM preferred) + 2.5 years, OR High School (or equivalent) + 3 years
- Previous cGMP experience
- Ability to follow SOPs and adhere to Good Documentation Practices (GDP)
- Understanding of process automation and software systems (e.g., LIMS)
Physical Requirements:
- Climb ladders, work in tight spaces, lift/move equipment up to 50 lbs
- Comfortable in cleanroom with gowning; stand up to 3 hours
Compensation/Benefits:
- Pay range: $31.25–$40.87
- Medical, dental, vision, life insurance; fitness/wellness reimbursement; short-/long-term disability; paid vacation (min 15 days) + end-of-year shutdown; paid holidays; sick time; maternity/parental leave; 401(k) with match; employee stock purchase plan; tuition reimbursement (up to $10,000/year); employee resource groups participation