Manufacturing Lead Associate - Nights

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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.

• 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 elevate 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.

• 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.
• Biotech Certificate and prior leadership experience would be ideal.
• Experience with systems such as SAP, LIMS and Track Wise would be ideal.
• Perform manufacturing and sampling operations using aseptic technique
• 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.
• Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMEA) to ensure inspection readiness of department.
• Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure.
• In the absence of the supervisor they are the person of authority.
• Expected to act on behalf of the supervisor while on the floor
• 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.

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This…