Lead Bio-Manufacturing Operator

Position Summary

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.

Key Responsibilities
• 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.

Additional Responsibilities
• 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.

Work Environment
• 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.

Minimum Qualifications
• 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 cross-functional support teams.
• Minimum of 2 years of experience in manufacturing, production, fermentation, biotechnology, food manufacturing, pharmaceutical manufacturing, or a related regulated environment.
• Demonstrated ability to safely and independently perform assigned manufacturing operations and follow established SOPs, work instructions, and standardized work.
• Working knowledge of GMP requirements, production documentation, traceability, sanitation, and workplace safety practices.
• Demonstrated mechanical aptitude and ability to assist with troubleshooting production processes and equipment.
• Ability to coordinate daily work activities, communicate priorities, and provide technical guidance to other team members.
• Ability to recognize process deviations, equipment concerns, quality issues, and safety risks and appropriately escalate them.
• Demonstrated ability to complete and review production records accurately, completely, and contemporaneously.
• Effective verbal and written communication skills, including the ability to provide clear shift handoffs and communicate production status to leadership.
• Demonstrated reliability, sound judgment, teamwork, and ability to work effectively with limited supervision.

Preferred Qualifications
• Previous experience guiding, training, or leading hourly team members.
• Experience working with fermentation production equipment, including bioreactors, centrifuges, freeze dryers, utilities, or related process equipment.
• Familiarity with cGMP, HACCP, FSMA, OSHA, food safety, or other regulated manufacturing requirements.
• Experience supporting equipment troubleshooting, production issue resolution, or coordination with Maintenance and Engineering teams.Associate degree or technical training in biotechnology, microbiology, fermentation, bioprocessing, food science, manufacturing technology, or a related field.
• 3+ years of experience in fermentation, bioprocessing, food, pharmaceutical, biotechnology, or other regulated manufacturing operations.
• Previous experience serving as a Lead Technician, Senior Technician, trainer, shift lead, or similar technical leadership role.
• Hands-on experience with fermentation/bioreactor operations, centrifugation, downstream processing, freeze drying or spray drying, CIP/SIP, utilities, and associated manufacturing equipment.
• Experience troubleshooting biological manufacturing processes and production equipment.
• Experience training, qualifying, or mentoring manufacturing personnel using standardized training methods or documented qualification programs.
• Experience with GMP documentation, batch records, deviation reporting, root-cause problem solving, and inspection readiness.
• Familiarity with continuous improvement, standardized work, Lean manufacturing, or similar operational excellence systems.
• Experience working with cross-functional groups such as Quality, Maintenance, Engineering, Inventory Control, and Production Planning.
• Familiarity with electronic manufacturing systems such as MES, ERP, CMMS, or electronic batch-record systems.

Technical Skills
• Ability to operate or support operation of process and utility equipment in a hygienic and safe manner.
• Knowledge of standard operating procedures, work instructions, production logs, cleaning records, and good documentation practices.
• Ability to support troubleshooting of production equipment and escalate issues appropriately.
• Understanding of regulated manufacturing practices, including cGMP, HACCP, FSMA, OSHA, and company safety guidelines.
• Ability to assist with documentation updates and ensure records are accurate, complete, and timely.
Non-Technical Skills
• Leadership and accountability.
• Dependability and ability to meet deadlines.
• Clear and respectful communication.
• Ability to provide feedback and support dispute resolution.
• Adaptability and flexibility.
• Honesty, courtesy, and respectfulness.
• Results-oriented mindset.
• Business acumen.
• Problem solving within company guidelines.
• Open and direct communication with coworkers and supervisors.

Licenses/Certifications
• No specific licenses or certifications required unless designated by the company.
• Food safety, HACCP, cGMP, OSHA, forklift, or other job-related certifications preferred, if applicable.

Physical & Safety Requirements
• Follow all SOPs, work instructions, food safety procedures, and company safety requirements.
• Operate process and utility equipment in accordance with processing procedures, cGMP, HACCP, FSMA, OSHA, and applicable company guidelines.
• Wear required personal protective equipment and follow hygiene, sanitation, and gowning requirements.
• Maintain manufacturing areas in a safe, clean, hygienic, and compliant condition.
• May be required to stand, walk, bend, reach, lift, carry, push, or pull materials or equipment as needed for the role.
• Must immediately report safety, quality, equipment, or food safety concerns to appropriate supervision.

Disclaimer
Adherence to all food safety procedures as per FDA regulations, including the FDA Food Safety Modernization Act (FSMA) or any other applicable federal, state, or local food safety regulations.