Lead Manufacturing Associate

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As a Lead Manufacturing Associate, you will deliver leadership and excellence in manufacturing processing and scheduling to meet site demands. You will oversee floor operations to ensure safety, aseptic operations and compliance to ensure 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.

• 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 materials and coordinate all materials deliveries
• Recommend/Implement process changes/improvements or safety/ergonomic improvements.
• Ensure work is carried out in a safe manner, notifying management of safety issues
• Tiered visual management and continuous improvement
• Support tech transfer activities
• Interview candidates
• Provide feedback on staff's performance
• Address minor personnel issues
• Escalate major personnel issue to the supervisor
• Ensure staff compliance with all relevant documentation and safety guidelines
• Initiate deviations or investigations of multiple complexities and work with different departments to identify root-cause
• Implement appropriate corrective actions
• Complete action items for GMP investigations and CAPA's
• Assist supervisor/engineer/facilities with investigations
• Revise and author GMP documentation
• Communicate any quality issues/concerns to Supervisor and QA
• Be a role model (Lead by Example)
• Be a resource/SME for staff
• Ensure the use of safe work practices and behaviors
• Conduct training and assess effectiveness
• Help identify training needs
• Assess staff skills and provide feedback to Supervisor.
• Develop training material
• Provide training
• Expected to act on behalf of the supervisor while on the floor

• Normally requires a high school diploma and 6+ years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing
• Biotech Certificate and prior leadership experience is ideal.
• Proficient in aseptic technique Operational knowledge of Systems and general equipment
• Experience with systems such as SAP, LIMS and Track Wise
• Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMA) to ensure inspection readiness of department.

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. You may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Flexibility to work according to the production schedule. This position will require weekend, holiday…