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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, Materials Planning and Logistics, Cell Therapies, you will support the routine operations of the cell therapy team and report to the Senior Manager of Manufacturing Supply Operations at Takeda's clinical cell processing facility in Cambridge, Massachusetts. You will coordinate global cell therapy material and product shipments, manage external warehousing activities, and develop long term strategies for critical raw material supply. You will also provide support services to the team during a manufacturing run including kitting, material delivery into production suites and other critical duties as needed. You will directly contribute to the successful delivery of novel cell products in support of human clinical trials.

How you will contribute:

• Manage shipments and logistics for cell therapy products and critical raw materials

• Maintain network of external warehouses and develop robust stock level strategy

• 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

• This position will require on-site work in cleanroom and warehouse spaces

Minimum Requirements/Qualifications:

• 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

• Experience with import/export of biological materials

• Knowledge of warehouse operations and material handling

• Ability to work weekends to support on-going manufacturing runs as required

• Ability to achieve and maintain gown qualification to work in an aseptic environment.

• 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 will inspire and empower you to grow through