Manufacturing Lead Associate - Nights

Role Summary

Manufacturing Lead Associate, Nights — lead manufacturing processing and scheduling to meet site demands, oversee floor operations for safety and compliance with cGMPs, manage material and equipment use, and provide technical support for process changes on the production floor. Reports to Manufacturing Supervisor.

Responsibilities

• Primary contact for troubleshooting, issue resolution or escalation; create and follow up on work orders; communicate daily scheduling and staffing plans, including reallocation of staff for breaks, lunch, and training.
• Provide oversight and execution of all routine and critical operations, including commissioning and validation activities; monitor material consumption and coordinate all material deliveries.
• Ensure documentation (forms, logbooks, form preps, batch records) is complete, reviewed, and meets good documentation practices; communicate schedule changes as needed; responsible for floor inventory.
• Recommend and implement process changes/improvements and safety or ergonomic improvements; ensure work is carried out safely, reporting safety issues and risks.
• Initiate deviations or investigations of various complexities; work with cross-functional teams to identify root causes, implement corrective actions, and complete GMP investigation/CAPA action items.
• Assist supervisor, engineer, or facilities with investigations; revise and author SOPs and batch records; communicate any quality issues or concerns to Supervisor and QA.
• Responsible for interviewing candidates; provide performance feedback; address minor personnel issues promptly and escalate major issues to the supervisor.
• Ensure staff compliance with relevant SOPs, batch records, form preps, and safety guidelines; act as a role model, SME, and resource for staff; ensure safe work practices and behaviors.

Qualifications

• Normally requires a high school diploma and 6+ years related industry experience or an Associates Degree in Life Sciences/Engineering with 5 years of GMP Manufacturing experience.
• Biotech Certificate and prior leadership experience would be ideal.
• Experience with systems such as SAP, LIMS and TrackWise would be ideal.
• Perform manufacturing and sampling operations using aseptic technique.
• Operational knowledge of CIP and SIP systems and general production equipment (autoclaves, water baths, pH/Conductivity meters, etc.).
• Knowledge of cGMPs and applicable agency regulations (FDA, EMEA) to ensure inspection readiness.
• Adaptability, positive outlook, and composure under pressure.
• In the absence of the supervisor, act as person of authority and on-floor representative.
• Prior experience with standardization and measurements using bench top equipment, aseptic processing, cell culture inoculation, scale-up processes, bioreactors and centrifuges, process automation and SAP.

Skills

• Leadership and team coordination
• Strong problem-solving and root-cause analysis
• Documentation and SOP/batch record proficiency
• Safety and compliance orientation
• Aseptic technique and cleanroom operations
• SAP, LIMS, TrackWise familiarity
• Communication and cross-functional collaboration

Education

• High school diploma or equivalent; Associate degree in Life Sciences/Engineering preferred
• Biotech certificate and leadership development would be beneficial

Additional Requirements

• Work in controlled manufacturing environments with gowning and protective clothing; potential need for respiratory protection around chemicals.
• Ability to work multiple shifts, including weekends, and adjust to production schedules.
• Ability to lift, push, or pull up to 25–50 lbs; stand for extended periods; climb ladders and work platforms as required.