Lead, Manufacturing
Biogen
8 days ago
On-site
Triangle, NC
Operations
About This Role
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. Works closely with the Shift Supervisor to coordinate critical activities collaboratively. Key preparatory role for Manufacturing Supervisor.
Responsibilities:
- Execute manufacturing processing steps/support activities; monitor process against batch record, SLR, and control system; coordinate/lead steps as needed as a process step expert.
- Schedule shift tasks and plan resource allocation (production, validation, and other project activities); ensure proper information sharing at shift exchange.
- Document and review cGMP data and deviations for processing/equipment activities per SOPs; develop/revise documents (batch records, SLRs, equipment logbooks); ensure completeness of BPR/SLR real-time review.
- Participate in training; manage individual training plan; provide training/coaching; observe performance and provide feedback to Supervisor mid/end of year.
- Initiate/investigate deviations; develop/implement CAPAs as required; lead/participate in troubleshooting; serve as SME for audits.
Who You Are
Agile self-starter who takes accountability, learns quickly, and prioritizes accurate/ethical data recordkeeping. Expert in multiple unit operations; skilled at leading, scheduling, training, and supporting associates. Key soft skills: teamwork, conflict resolution, teachability, patience, and following procedures.
Qualifications
Required:
- Bachelor’s (engineering/science) preferred + 4 years direct biomanufacturing experience
- Associate (engineering/science) preferred + 4.5 years direct biomanufacturing experience
- Certificate or HS diploma (engineering/science) preferred + 5 years direct biomanufacturing experience
Preferred:
- Prior purification experience in a leadership capacity
- Lean, Six Sigma, and 5S certifications
- Experience with Trackwise, Delta V, and LIMS, plus cGMP experience
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. Works closely with the Shift Supervisor to coordinate critical activities collaboratively. Key preparatory role for Manufacturing Supervisor.
Responsibilities:
- Execute manufacturing processing steps/support activities; monitor process against batch record, SLR, and control system; coordinate/lead steps as needed as a process step expert.
- Schedule shift tasks and plan resource allocation (production, validation, and other project activities); ensure proper information sharing at shift exchange.
- Document and review cGMP data and deviations for processing/equipment activities per SOPs; develop/revise documents (batch records, SLRs, equipment logbooks); ensure completeness of BPR/SLR real-time review.
- Participate in training; manage individual training plan; provide training/coaching; observe performance and provide feedback to Supervisor mid/end of year.
- Initiate/investigate deviations; develop/implement CAPAs as required; lead/participate in troubleshooting; serve as SME for audits.
Who You Are
Agile self-starter who takes accountability, learns quickly, and prioritizes accurate/ethical data recordkeeping. Expert in multiple unit operations; skilled at leading, scheduling, training, and supporting associates. Key soft skills: teamwork, conflict resolution, teachability, patience, and following procedures.
Qualifications
Required:
- Bachelor’s (engineering/science) preferred + 4 years direct biomanufacturing experience
- Associate (engineering/science) preferred + 4.5 years direct biomanufacturing experience
- Certificate or HS diploma (engineering/science) preferred + 5 years direct biomanufacturing experience
Preferred:
- Prior purification experience in a leadership capacity
- Lean, Six Sigma, and 5S certifications
- Experience with Trackwise, Delta V, and LIMS, plus cGMP experience