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Job Description

About the role:

As a Senior Manufacturing Associate, you will perform manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. Will support engineering and validation activities.

How you will contribute:

• You will perform cGMP manufacturing operations.

• Standard Operating Procedures (SOP), Batch Records and Form

• Troubleshoot and escalate process related issues Create work orders

• Initiate and document minor deviations

• Execute critical, routine and non-routine production operations

• Inform management of events impacting schedule

• request and execution of GMP documentation

• Enter data in the Laboratory Information Management System (LIMS), MODA and other business system

• Review manufacturing documentation real time to ensure compliance

• Coordinate sample preparation and testing

• Propose and review document revisions

• Carry out work in a safe manner, notifying management of safety issues and risks

• Participate in tiered visual management system and support continuous improvement initiatives

• Initiating work orders

• Act as subject matter expert for improvement projects

• Perform scheduled cleaning of equipment

• Assembly and disassembly of process equipment

• Perform standardization of equipment

• Support change over activities

• Build equipment and process qualifications and validation

• Provide technical training for area personnel

• Contribute to training material development

• Maintain training requirements and act as a qualified trainer as required

• Develop and maintain personal development plan

• Provide annual performance self-assessment

What you bring to Takeda:

• Normally requires a high school diploma and 4+ years of experience or an associate's degree in Life Sciences/Engineering field with 3 years of GMP Manufacturing experience.

• Biotech certification preferred

• Will be required to perform as a subject matter expert for equipment and/or systems

• The individual is proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.

• Possess excellent communication and troubleshooting skills.

• Full awareness of current Good Manufacturing Practices.

• Proficient computer skills.

• Proficient in Aseptic Technique

• Work cohesively in a team environment

• Experience with business systems such as, LIMs, MODA and other business systems

• Clear understanding of manufacturing processes and the ability to readily identify deviations in process, controls, and guidelines required.

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:

• 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