Lead Bio-Manufacturing Operator

The Bio-Manufacturing Team Lead, serves as the senior technical resource and day-to-day execution lead for the assigned production crew. The Lead Technician coordinates work, supports troubleshooting, reinforces standardized work, and assists with employee training while remaining actively involved in production. This role provides technical and workflow leadership but does not replace the Supervisor’s or Manager's responsibility for employee management, performance management, discipline, staffing accountability, or overall shift ownership.

• Guide and support hourly Bio-Manufacturing personnel assigned to the shift, ensuring team members understand daily priorities, work assignments, safety expectations, and production requirements.
• Coordinate daily work assignments and production activities across the crew in alignment with the production schedule and priorities established by Bio-Manufacturing leadership.
• Assign personnel to shift activities based on production needs, employee capabilities, training status, safety requirements, and operational priorities.
• Support safe and effective execution of fermentation, harvest, downstream processing, cleaning, preparation, material handling, and other qualified Bio-Manufacturing operations.
• Serve as a technical resource for process execution, abnormal operating conditions, startup and shutdown activities, tank turnaround, and routine troubleshooting.
• Identify and assist with troubleshooting process and equipment issues, escalating deviations, quality concerns, safety risks, equipment failures, and unresolved operational issues to the appropriate leadership or support function.
• Monitor execution across the work area and communicate production status, risks, delays, staffing needs, equipment concerns, and resource needs to Bio-Manufacturing leadership in a timely manner.
• Coordinate with Bio-Manufacturing leadership and cross-functional teams, including Quality, Engineering, Maintenance, and other support functions, to address operational needs and maintain production and equipment readiness.
• Ensure effective shift handoffs and reinforce accurate, complete, and contemporaneous production documentation, including appropriate traceability of activities and materials.
• Support onboarding, hands‑on training, task qualification, and continued development of Bio-Manufacturing Technicians while reinforcing approved procedures and work practices.
• Reinforce compliance with SOPs, guidance documents, GMP requirements, safety expectations, and standardized work; identify departures from established standards and help restore the process to the approved condition.
• Support production readiness, housekeeping, organization, and inspection‑ready conditions throughout the work area, while providing operational leadership and coordination support to the Supervisor or Manager.

• Assist with writing, completing, reviewing, and updating shift documentation, including production records, logs, cleaning records, maintenance records, and other required manufacturing documentation.
• Maintain accurate written records or logs of production processes, cleaning activities, and maintenance completed during the shift.
• Assist in maintaining process areas within the manufacturing environment to comply with current regulatory guidelines and internal procedures.
• Promote a clean, hygienic, organized, and inspection‑ready work environment.
• Complete other duties as assigned to support department and business needs.

• Works in a regulated bio-manufacturing, fermentation, or food manufacturing environment.
• May work around bioreactors, centrifuges, freeze dryers, utilities, cleaning chemicals, and other production or support equipment.
• Requires adherence to hygiene, sanitation, gowning, personal protective equipment, safety, quality, and regulatory procedures.
• May require standing for extended periods and working in manufacturing areas with varying temperatures, noise levels, or wet conditions.

• High school diploma or equivalent required.
• Prior experience in fermentation, bio-manufacturing, food manufacturing, pharmaceutical manufacturing, or another regulated production environment.
• Ability to follow standard operating procedures, work instructions, safety rules, and quality requirements.
• Ability to maintain accurate production, cleaning, and maintenance documentation.
• Ability to communicate clearly with team members, supervisors, and…