Production Lead

Key Responsibilities

• Coordinate and lead daily manufacturing activities within a cleanroom environment
• Provide real-time support to technicians during batch execution
• Verify line clearance, material readiness, and equipment status prior to production
• Ensure adherence to GMP documentation practices (batch records, logbooks, checklists)
• Review production paperwork for completeness and accuracy
• Escalate and help investigate deviations, nonconformances, and process issues
• Partner with Quality to support investigations and corrective actions
• Maintain an inspection-ready area through proper housekeeping and organization
• Train and mentor operators on aseptic behaviors and procedural compliance
• Support shift handoffs and communicate production status across teams
• Identify opportunities to improve efficiency, workflow, and compliance practices

Required Background

• Experience working in regulated manufacturing (pharma, biotech, biologics, sterile, or medical device)
• Hands-on work inside a cleanroom or controlled environment
• Experience guiding, training, or leading operators/technicians
• Familiarity with batch documentation and quality systems
• Ability to follow and enforce procedures with a strong quality mindset
• Strong communication and organizational skills

Preferred Experience

• Aseptic processing or sterile manufacturing
• Fill-finish, injectable, biologics, or advanced therapies manufacturing
• Deviation investigations / CAPA support
• Audit or inspection readiness activities
• SOP authorship or revisions

Work Environment

• Cleanroom gowning and PPE required
• Fast-paced, team-oriented production setting
• Standing and moving within manufacturing areas for extended periods
• Occasional extended hours or schedule flexibility based on production needs