Lead Manufacturing Associate - Night Shifts

Role Summary

Lead Manufacturing Associate - Night Shifts. Deliver leadership and excellence in manufacturing processing and scheduling to meet site demands, oversee floor operations to ensure safety, aseptic operations and cGMP compliance, and provide technical support to transfer process changes to floor operations. 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 safely; notify management of safety issues; support QA; assist with tech transfer activities.
• Interview candidates, provide feedback on staff performance, and address minor personnel issues; escalate major issues to the supervisor.
• Be a role model and a resource/SME for staff; conduct training and assess effectiveness; identify training needs and provide feedback to Supervisor.
• Develop training material; initiate deviations or investigations; work with departments to identify causes; implement corrective actions and complete action items for GMP investigations and CAPAs.
• Assist supervisor/engineer/facilities with investigations and revise/author GMP documentation; communicate quality issues 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.
• Ability to work in a team environment and communicate with all levels throughout the organization.
• Demonstrates adaptability, maintains positive outlook, and composure under pressure.

Education

• Not specified beyond above qualifications.

Additional Requirements

• Work in a controlled environment requiring gowning and protective clothing; potential need for hearing protection in loud areas.
• Remove makeup, jewelry, contact lenses, nail polish, and artificial nails in manufacturing environment.
• Work in a cold, wet environment; ability to lift 25‚Äì50 lbs; stand up to 6 hours; climb ladders; bend or stoop; work around chemicals requiring respiratory protection.
• Ability to work multiple shifts, including weekends and overtime as necessary; position considered essential personnel.