Lead Manufacturing Associate - Night Shifts

Role Summary

Lead Manufacturing Associate - Night Shifts. Lead and oversee manufacturing operations to meet site demands, ensuring safety, aseptic practices, and cGMP compliance. Manage floor operations, allocate personnel, and drive continuous improvement and tech transfer activities. Reports to Manufacturing Supervisor. This is a night shift role.

Responsibilities

• Primary contact for troubleshooting and issue resolution, create and follow-up on work orders, and coordinate scheduling and staffing.
• Re-allocate staff for breaks, lunch, and training.
• Oversee routine and critical operations, commissioning, and changeover validation activities.
• Ensure documentation is complete and complies with good documentation practices.
• Manage floor inventory and communicate schedule changes; monitor material usage and coordinate deliveries.
• Recommend and implement process changes, safety, and ergonomic improvements.
• Maintain safe work practices, escalate safety issues, support continuous improvement and tech transfer activities.
• Interview candidates, provide feedback on performance, and address personnel issues; escalate major issues to supervisor.
• Lead by example, act as SME for staff, and train and assess staff, including identifying training needs.
• Develop training materials and initiate deviations or investigations as needed; implement corrective actions for GMP investigations and CAPAs.
• Assist supervisor/engineer/facilities with investigations and revise GMP documentation; communicate quality issues to supervisor and QA.

Qualifications

• High school diploma with 6+ years related industry experience, or 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) for inspection readiness.
• Ability to work in a team and communicate at all levels; adaptability and composure under pressure.

Skills

• Leadership and people management
• Manufacturing operations and floor control
• Documentation and batch record management
• Process improvement and CAPA implementation
• Technical troubleshooting and problem solving

Education

• High school diploma or Associate's Degree in Life Sciences/Engineering (as applicable per qualifications above)

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.
• Ability to lift 25‚Äì50 lbs, stand for up to 6 hours, and work in controlled, protective environments.
• Willingness to work weekends/holidays/overtime as needed; essential personnel in weather events.