Lead, Manufacturing

Role Summary

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, and maintaining equipment and facilities. This role collaborates with the shift Supervisor to coordinate activities, optimize resource use, and serves as a preparatory step for the Manufacturing Supervisor position.

Responsibilities

• Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR, and control system; serves as a process step expert.
• Schedules tasks for a given shift in coordination with the Supervisor and plans resource allocation, including production, validation, or other project activities; ensure effective information sharing at shift exchanges and proper communication of issues.
• Documents/records and reviews cGMP data and information (including deviations) for processing steps and/or equipment activities, following SOPs; develops/revises documents as needed; ensures completeness of BPR/SLR real-time review.
• Participates in training activities, manages their own training plan, provides training to others, observes performance, and provides coaching and feedback to the Supervisor.
• Initiates/investigates deviations, develops and implements corrective and preventative actions, leads/troubleshoots, and serves as a subject matter expert for audits.

Qualifications

• Required: Bachelor’s Degree in an engineering or scientific discipline with 4 years of direct biomanufacturing experience OR 4 years of direct biomanufacturing experience with an Associate degree in an engineering or scientific discipline.
• Required: Certificate or high school diploma in an engineering or scientific discipline with 5 years of direct biomanufacturing experience.
• Preferred: Prior Parenteral Filling experience in a leadership capacity.
• Preferred: Lean, Six Sigma, and 5S certifications.
• Preferred: Experience with Trackwise, DeltaV, and LIMS in addition to cGMP experience.