Lead, Manufacturing - Solution Prep (Days)
Biogen
August 14, 2026
On-site
Triangle, NC
Operations
Shift Details:
- 2-2-3 calendar rotation on days (6:00 AM–6:00 PM ET)
The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment, including operating process equipment, executing validation protocols, revising cGMP documents, ensuring cGMP compliance, and maintaining equipment and facilities. Works closely with the shift Supervisor; serves as a key preparatory role for Manufacturing Supervisor.
What You’ll Do
- Execute manufacturing processing steps/support activities; monitor against batch record, SLR, and control system; coordinate/lead as process step expert.
- In coordination with Supervisor: schedule shift tasks, plan resource allocation (production/validation/projects), ensure proper information sharing at shift exchange, and communicate issues.
- Document/record and review cGMP data; document deviations; develop/revise documents (batch records, SLRs, equipment logbooks); ensure BPR/SLR real-time review completeness.
- Participate in training; manage individual training plan; train others; coach and provide feedback to Supervisor.
- Initiate/investigate deviations; develop/implement CAPAs; lead/participate in troubleshooting; serve as possible SME for audits.
- Serve as operational point of contact during assigned shifts for technical guidance and real-time decisions.
Required Skills
- Bachelor’s (STEM preferred) + 4 years; or BioWorks certificate/associate’s (STEM) + 4.5 years; or HS (or equivalent) + 5 years.
- Leading manufacturing activities; coordinating across shift team; training in cGMP.
- Follow SOPs and GDP.
- Aseptic/cleanroom experience.
- Downstream/buffer prep experience in cGMP.
- Trackwise, Delta V, Syncade, LIMS (or similar).
Preferred Skills
- Leadership experience in buffer prep/downstream.
- Lean, Six Sigma, 5S certifications.
Benefits (as listed)
- Medical, dental, vision, life; fitness reimbursement; short-/long-term disability; paid vacation (min 15 days) plus Dec 26–Dec 31 shutdown; holidays and paid personal days; sick time; paid maternity/parental leave; 401(k) match; stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.
- 2-2-3 calendar rotation on days (6:00 AM–6:00 PM ET)
The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment, including operating process equipment, executing validation protocols, revising cGMP documents, ensuring cGMP compliance, and maintaining equipment and facilities. Works closely with the shift Supervisor; serves as a key preparatory role for Manufacturing Supervisor.
What You’ll Do
- Execute manufacturing processing steps/support activities; monitor against batch record, SLR, and control system; coordinate/lead as process step expert.
- In coordination with Supervisor: schedule shift tasks, plan resource allocation (production/validation/projects), ensure proper information sharing at shift exchange, and communicate issues.
- Document/record and review cGMP data; document deviations; develop/revise documents (batch records, SLRs, equipment logbooks); ensure BPR/SLR real-time review completeness.
- Participate in training; manage individual training plan; train others; coach and provide feedback to Supervisor.
- Initiate/investigate deviations; develop/implement CAPAs; lead/participate in troubleshooting; serve as possible SME for audits.
- Serve as operational point of contact during assigned shifts for technical guidance and real-time decisions.
Required Skills
- Bachelor’s (STEM preferred) + 4 years; or BioWorks certificate/associate’s (STEM) + 4.5 years; or HS (or equivalent) + 5 years.
- Leading manufacturing activities; coordinating across shift team; training in cGMP.
- Follow SOPs and GDP.
- Aseptic/cleanroom experience.
- Downstream/buffer prep experience in cGMP.
- Trackwise, Delta V, Syncade, LIMS (or similar).
Preferred Skills
- Leadership experience in buffer prep/downstream.
- Lean, Six Sigma, 5S certifications.
Benefits (as listed)
- Medical, dental, vision, life; fitness reimbursement; short-/long-term disability; paid vacation (min 15 days) plus Dec 26–Dec 31 shutdown; holidays and paid personal days; sick time; paid maternity/parental leave; 401(k) match; stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.