Production Lead

The Production Lead supports clinical trial projects through the packaging of clinical trial supplies by ensuring that all work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). The Production Lead is responsible for the overall process for the area, ensuring on-time startup and effective and compliant processing through the shift.

Requirements

• Review packaging batch records before, during, and after production to ensure accuracy, completeness, and adherence to SOPs and cGMP
• Prepare, complete, and maintain all required documentation and metric sheets in compliance with regulatory and internal standards
• Inspect drug products, components, and clinical labels for defects, blemishes, or missing text throughout production
• Perform Job Safety Analysis (JSA) on new equipment and verify setup compliance against JSAs, batch records, and SOPs
• Attend project kickoff meetings and contribute effectively to planning and follow-through activities
• Provide frontline leadership and decision-making for Packaging and Room operations
• Support supervisors with daily operational tasks, scheduling of planned maintenance, coordinating Ready‐to‐Execute status, and managing competing priorities
• Perform Gemba walks and assist with completing action items, including corrections or CAPAs within TrackWise
• Assist in Safety and Quality investigations using Root Cause Assessment techniques and support CAPA development and implementation
• Must be able to follow written and oral instructions in an accurate manner and problem-solve using analytical skills and/or Lean Six Sigma/5S methodology
• Must be able to work overtime as required
• Physical requirements: able to perform duties which include standing, walking, sitting, kneeling, push/pulling frequently and significant amount of use of office equipment; Must be able to lift up to 35lbs and work in temperature-controlled freezers/fridges frequently.

Benefits

• Paid Time Off accrual
• Medical, dental and vision benefits
• 401K match
• Tuition Reimbursement
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
• WellHub program to promote overall physical wellness