Lead, Manufacturing - Cell Culture (Nights)

Biogen; Asheville (NC); On-site; USD 45,000 - 59,000; Full time

Job summary

Biogen seeks a Manufacturing Lead for cell culture operations at its Research Triangle Park facility. The role involves 12-hour night shifts (6 PM–6 AM) on a rotating schedule, executing cGMP manufacturing processes, coordinating shift activities, and mentoring associates in a 24/7 production environment.

Responsibilities include leading upstream unit operations, documenting compliance data, and supporting deviations and CAPAs within a regulated setting.

Qualifications

• Bachelor's degree in STEM and 4+ years of direct manufacturing experience in cGMP settings.
• Demonstrated leadership in manufacturing activities, shift coordination, and associate training.
• Proficiency following SOPs and Good Documentation Practices.
• Upstream cell culture manufacturing experience in pharmaceutical/biotech or regulated environments.
• Aseptic or cleanroom environment experience.

Responsibilities

• Execute cell culture processing steps and manufacturing support activities while monitoring batch records and process controls.
• Serve as SME for upstream unit operations and lead critical manufacturing activities.
• Coordinate shift activities including production execution, validation, and resource planning with the Shift Manager.
• Document and verify cGMP data, record deviations, and develop or revise manufacturing documents as needed.
• Train and mentor Manufacturing Associates, conduct performance observations, and lead deviation investigations and corrective actions.

Skills

Leadership

Shift coordination

cGMP documentation

Quality systems

Aseptic processing

Education

Bachelor's degree in STEM

Tools

Trackwise

DeltaV

Syncade

LIMS

Job description

Manufacturing Lead position in cell culture operations at Biogen's Research Triangle Park facility, working 12-hour night shifts (6 PM–6 AM) on a rotating schedule. Responsible for executing cGMP manufacturing processes, coordinating shift activities, documenting compliance data, and mentoring manufacturing associates in a 24/7 production environment.

Responsibilities

• Execute cell culture processing steps and manufacturing support activities while monitoring batch records and process controls
• Serve as subject matter expert for upstream unit operations and lead critical manufacturing activities
• Coordinate shift activities including production execution, validation, and resource planning with the Shift Manager
• Document and verify cGMP data, record deviations, and develop or revise manufacturing documents as needed
• Train and mentor Manufacturing Associates, conduct performance observations, and lead deviation investigations and corrective actions

Requirements

• Bachelor's degree in STEM with 4+ years direct manufacturing experience, or equivalent credential and experience combination
• Demonstrated leadership in manufacturing activities, shift coordination, and associate training within cGMP settings
• Proficiency following Standard Operating Procedures and Good Documentation Practices
• Upstream cell culture manufacturing experience in pharmaceutical, biotechnology, or regulated manufacturing
• Aseptic or cleanroom environment experience
• Familiarity with manufacturing systems such as Trackwise, Delta V, Syncade, or LIMS

Compensation: $33.17-$43.27 per hour