Lead, Manufacturing
Biogen
July 02, 2026
On-site
Triangle, NC
Operations
The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment, including operation of process equipment, execution of validation protocols, revising cGMP documents, ensuring compliance to cGMP, and maintaining equipment and facilities. This role coordinates critical activities with the shift Supervisor and is a key preparatory role for the Manufacturing Supervisor position.
Responsibilities:
- Execute manufacturing processing steps and/or manufacturing support activities; monitor process against batch record, SLR, and control system; coordinate/lead process steps as required.
- With Supervisor input, schedule shift tasks and plan resource allocation (production, validation, other project activities); ensure proper information sharing at shift exchange.
- Document and review cGMP data/information (including deviations) per SOPs; develop/revise documents (batch records, SLRs, equipment logbooks); ensure completeness of BPR/SLR real-time review.
- Participate in training; manage personal training plan; provide training/coaching to associates; provide feedback to Supervisor mid/end of year.
- Initiate/investigate deviations; develop/implement CAPAs as required; lead/participate in troubleshooting; serve as possible SME for audits.
Qualifications:
- Required: Bachelor’s in engineering/science (preferred) + 4 years direct biomanufacturing experience; or Associate degree (preferred) + 4.5 years; or Certificate/HS diploma (preferred) + 5 years.
- Preferred: Prior purification experience in leadership capacity; Lean/Six Sigma/5S certifications; Trackwise, Delta V, LIMS experience plus cGMP.
Benefits (as stated): Medical, dental, vision, life; fitness/wellness reimbursement; short- and long-term disability; paid vacation + end-of-year shutdown; company paid holidays + personal significance days; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.
Job Level: Professional
Responsibilities:
- Execute manufacturing processing steps and/or manufacturing support activities; monitor process against batch record, SLR, and control system; coordinate/lead process steps as required.
- With Supervisor input, schedule shift tasks and plan resource allocation (production, validation, other project activities); ensure proper information sharing at shift exchange.
- Document and review cGMP data/information (including deviations) per SOPs; develop/revise documents (batch records, SLRs, equipment logbooks); ensure completeness of BPR/SLR real-time review.
- Participate in training; manage personal training plan; provide training/coaching to associates; provide feedback to Supervisor mid/end of year.
- Initiate/investigate deviations; develop/implement CAPAs as required; lead/participate in troubleshooting; serve as possible SME for audits.
Qualifications:
- Required: Bachelor’s in engineering/science (preferred) + 4 years direct biomanufacturing experience; or Associate degree (preferred) + 4.5 years; or Certificate/HS diploma (preferred) + 5 years.
- Preferred: Prior purification experience in leadership capacity; Lean/Six Sigma/5S certifications; Trackwise, Delta V, LIMS experience plus cGMP.
Benefits (as stated): Medical, dental, vision, life; fitness/wellness reimbursement; short- and long-term disability; paid vacation + end-of-year shutdown; company paid holidays + personal significance days; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.
Job Level: Professional