Manufacturing Lead Associate - Nights

Role Summary

As Manufacturing Lead Associate, you will deliver leadership and excellence in manufacturing processing and scheduling to meet site demands. Oversees floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained. Ensure efficient use of material and equipment and assign personnel in the execution of daily operations. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Provide support to integrate best practices into manufacturing. You will report 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, subject matter expert (SME), and resource for staff; ensure safe work practices and behaviors.

Qualifications

• Required: Normally requires a high school diploma and 6+ years related industry experience or an Associates Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing experience.
• Preferred: Biotech Certificate and prior leadership experience would be ideal.
• Preferred: Experience with systems such as SAP, LIMS and TrackWise.
• Required: Perform manufacturing and sampling operations using aseptic technique.
• Required: Operational knowledge of Clean-in-Place (CIP) and Steam-in-place (SIP) Systems and general production equipment such as Autoclaves, water baths, pH/Conductivity meters etc.
• Required: Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMEA) to ensure inspection readiness of department.
• Required: Demonstrates adaptability, maintains positive outlook, and composure under pressure.
• Required: In the absence of the supervisor they are the person of authority and expected to act on behalf of the supervisor while on the floor.
• Preferred: Prior experience or exposure to standardization and measurements utilizing bench top equipment, aseptic processing, cell culture inoculation and scale up processes, use of bioreactors and centrifuges in the growth of cell cultures, process automation and SAP Enterprising Resource Platform.

Skills

• Aseptic technique
• Process troubleshooting and issue resolution
• Documentation and batch record management
• Root cause analysis and CAPA
• Cross-functional collaboration
• Attention to safety and compliance
• ERP/LIMS/TrackWise familiarity
• Leadership and team supervision

Education

• High school diploma or equivalent; or Associate’s Degree in Life Sciences/Engineering
• Biotech Certificate (preferred)

Additional Requirements

• Work in a controlled environment requiring gowning and protective clothing; may require respiratory protection in some areas.
• Work in cold, wet environments and on multiple shifts, including weekends or supplemental hours as necessary.
• Ability to lift, pull, or push equipment up to 25–50 lbs; stand for extended periods; climb ladders and work platforms; stoop or bend to troubleshoot equipment.
• Ability to work around chemicals (e.g., alcohols, acids, bases) and follow safety guidelines.