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Job Description

About the role:

As the Manufacturing Lead, you will complete all processes in production while strictly following cGMP, environmental health and safety guidelines and any other related regulations which could apply. You will participate in both departmental projects and any quality working teams which may be applicable. Under the overall direction of the supervisor, this position shall manage all activities in the production area. In addition to being accountable and involved in all production processes, you may in other areas. You will be a delegate to the supervisor and may conduct departmental activities in their absence. You will understand the regulations and may make recommendations according to their interpretations. You will manage the successful transfer of new processes/methodologies into the manufacturing area.

How you will contribute:

• Supports all local manufacturing operations.
• Assist supervisor in organizing, scheduling and directing other team members.
• Conduct shift change meeting in lieu of shift supervisor.
• Troubleshoot process problems and respond to process alarms. Main troubleshooting/response person.
• Operate general production equipment for the assigned area.
• Prepare media and buffer solutions.
• Main interface with other departments to resolve issues related to equipment, process, and compliance, including maintenance, metrology, and validation.
• Complete relevant paperwork following GDP/GMP guidelines.
• Write, revise and review important documentation.
• Participate on Continuous Improvement Teams and may serve in a leadership role.
• Represent the department in teams.
• Initiate and coordinate other process improvement projects.
• Train other team members.
• Help with process/equipment validation and data analysis.
• Assign other project work and involvement in teams to team members.
• Perform removal of hazardous waste.
• Complete material transfers including non-hazardous, hazardous and flammable chemicals to support manufacturing schedule adherence.
• Maintain a visual replenishment program of materials using lean manufacturing processes.
• Maintain records of materials in inventory and on order.
• Compile inventory records.
• Reconcile discrepancies in inventories.
• Compile information on receipt and transfer of materials.
• Resolve questions and problems and refer only most complex issues to higher levels.
• Contribute to a culture of safety first in compliance with Environmental, Health, and Safety (EHS). Understand Job Hazard Analysis (JHA) packets.

What you bring to Takeda:

• Typically requires high school diploma or GED plus 6+ years of experience or associates' degree or higher with 4+ years related work experience.
• Will apply quantitative analysis to analyze process performance.
• You must be proficient in multiple mathematical disciplines and be able to work with both the metric and USA standards of measurement.
• Knowledge of basic chemical and biological safety procedures.
• Must have experience with inventory management.
• Experience handling pallet-jacks, pallet trucks, and forklifts.

Important Considerations

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:

• May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• Need to remove all make-up, jewelry, cont