Lead, Manufacturing

About the Role The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment, including operation of process equipment, execution of validation protocols, and revision of cGMP documents. This role works closely with the shift supervisor to coordinate critical activities, optimize resources, and serves as a key preparatory step for the Manufacturing Supervisor position. What You'll Do

• Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR, and control system; acts as a process step expert.
• In coordination with the Supervisor, schedules tasks for the shift and plans resource allocation (production, validation, and other project activities); ensures effective shift handoffs and issue communication.
• Documents/records and reviews cGMP data and information (including deviations) for processing steps and/or equipment activities; develops/revises documents as needed; maintains batch records, SLRs, and equipment logbooks; ensures completeness of BPR/SLR real-time review.
• Actively participates in training, manages own training plan, and provides training to other associates; mentors and coaches staff.
• Observes performance, provides timely coaching, and communicates feedback to the Supervisor.
• Initiates/investigates deviations and leads CAPA development and implementation; participates in troubleshooting; serves as a SME for audits. What We're Looking For
• Bachelor’s Degree in an engineering or scientific discipline with a minimum of 4 years of direct biomanufacturing experience.
• Associate degree in an engineering or scientific discipline with a minimum of 4.5 years of direct biomanufacturing experience.
• Certificate or HS diploma in an engineering or scientific discipline with a minimum of 5 years of direct biomanufacturing experience.
• Preferred: Prior Purification experience in a leadership capacity; Lean, Six Sigma and 5S certifications; experience with Trackwise, DeltaV, and LIMS in addition to cGMP experience. Nice to Have
• Prior purification leadership experience.
• Additional lean/six-sigma certifications.
• Strong problem-solving and communication skills. Compensation & Benefits
• Base compensation range not disclosed in the posting.