Lead Manufacturing Associate - Night Shifts

Role Summary

Lead Manufacturing Associate - Night Shifts. Lead and manage manufacturing processing and scheduling to meet site demands, ensure safety and cGMP compliance on the floor, and support process transfers and improvements. Reports to Manufacturing Supervisor.

Responsibilities

• Primary contact for troubleshooting and issue resolution or escalation, create and follow-up on work orders, communicate/coordinate days scheduling and staffing plan.
• Re-allocate staff during the day (breaks, lunch, training).
• Oversight and execution of all routine and critical operations and commissioning and changeover validation activities.
• Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, form preps, batch records).
• Responsible for floor inventory and communicating schedule changes.
• Monitor material usage and coordinate all materials deliveries.
• Recommend/implement process changes/improvements or safety/ergonomic improvements.
• Ensure work is carried out in a safe manner, notify management of safety issues, support continuous improvement and tech transfer activities.
• Interview candidates, provide feedback on staff's performance and address minor personnel issues.
• Escalate major personnel issue to the supervisor, ensure staff compliance with all relevant documentation and safety guidelines.
• Be a role model and SME for staff; use safe work practices and behaviors.
• Conduct training and assess effectiveness, identify training needs, assess staff skills and provide feedback to Supervisor.
• Develop training material, initiate deviations or investigations of multiple complexities and work with departments to identify cause.
• Implement corrective actions and complete action items for GMP investigations and CAPAs.
• Assist supervisor/engineer/facilities with investigations, revise and author GMP documentation.
• Communicate quality issues/concerns to Supervisor and QA, provide training, and act on behalf of the supervisor on the floor.

Qualifications

• Normally requires a high school diploma and 6+ years related industry experience or an Associate's Degree in Life Sciences/Engineering with 5 years of GMP Manufacturing experience.
• Proficient in aseptic technique.
• Operational knowledge of systems and general equipment.
• Knowledge of cGMPs and applicable agency regulations (FDA, EMA) to ensure inspection readiness.
• Work in a team environment; communicate with all levels.
• Adaptability, positive attitude, and composure under pressure.

Skills

• Leadership and people management on the manufacturing floor.
• Process optimization and continuous improvement.
• Documentation and batch record management.
• Problem solving and trouble-shooting on complex equipment and processes.
• Training delivery and materials development.

Education

• High school diploma or Associate's Degree in Life Sciences/Engineering (preferred).

Additional Requirements

• Ability to work night shifts (6:00 p.m. ‚Äì 6:00 a.m.) on a rotating 2-2-3 schedule, including every other weekend.
• Work in controlled environment with gowning and protective clothing; potential exposure to cold, wet environments and chemicals; ability to lift 25‚Äì50 lbs; stand for up to 6 hours; climb ladders and work platforms.
• Weekend, holiday, and overtime work as required; essential personnel with potential weather-related requirements.