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Job Description

About the role: 

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

As a Senior Specialist, Manufacturing Supply Operations, Cell Therapies, working on the Cell Therapy GMP Manufacturing Supply Operations team, you will be empowered to support the manufacturing of Takeda’s Cell Therapy products and work with cross-functional peers to support clean room activities. 

How you will contribute:   

The role will support the routine operations of the cell therapy manufacturing team and report to the Senior Manager of Manufacturing Supply Operations at Takeda’s clinical cell processing facility in Cambridge, Massachusetts. The position will provide support services to the team during a manufacturing run including kitting, material delivery into production suites and other critical duties as needed. This position will directly contribute to the successful delivery of novel cell products in support of human clinical trials.                                 

• Execute warehouse and material operations, including material onboarding, material receipt and release, inventory management, kitting operations and material reconciliation

• Follow Standard Operating Procedures (SOPs) in compliance with Current Good Manufacturing Practices (cGMP).

• Provide support in classified spaces during execution of operations for manufacturing of patient therapies according to SOPs and cGMP, regulatory and safety requirements.

• Ensure all training assignments are complete and up to date, to maintain necessary technical skills and knowledge

• Ensure processing equipment and required materials are available, maintained, and qualified as required for the different manufacturing activities

• Support investigations in manufacturing and technical deviations

• Actively participate in problem identification, problem solving, and change initiatives in cooperation with other teams and functions

Minimum Requirements/Qualifications: 

Education and Experience:

• For Senior Specialist: Bachelors degree in biotechnology, biology, chemistry, pharmacy, engineering or related pharmaceutical science and 4+ years relevant industry experience or Masters degree in biotechnology, biology, chemistry, pharmacy, engineering or related pharmaceutical science and 2+ years relevant industry experience.

• Solid knowledge of cGxP regulations.

• Basic knowledge of warehouse operations and material handling.

• Ability to work weekends to support on-going manufacturing runs.

• Ability to obtain and maintain qualified gowning status.

Physical Requirements:

• Work is generally performed in a GMP manufacturing facility and may require extended periods of standing (4 hours)/

• Ability to lift, pull, or push equipment requiring up to 25-50 lbs. of force/

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that wil