Lead, Manufacturing - Cell Culture (Nights)

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