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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.

Join Takeda as a Senior Specialist Cell Therapy Manufacturing Operations where your primary focus will be cGMP cell therapy manufacturing at Takeda's new cell processing facility in Cambridge, Massachusetts. You will directly contribute to the successful delivery of novel cell products in support of human clinical trials.

How you will contribute:

• Lead and execute unit operations for manufacturing of patient therapies according to standard operating procedures and cGMP, regulatory and safety requirements. Duties include basic cell culture as well as specialized techniques for cell selection, activation, transduction, and purification.

• Perform operations in a cleanroom environment, using proper controls to assure aseptic processing includes gowning, cleaning, and isolation procedures.

• Perform supporting operations as needed including preparation of consumables, media blending, cleaning, and environmental monitoring.

• Complete all daily manufacturing tasks following standard operating procedures and batch document instructions, completing forms, reports, logs and records of equipment, and batches as required.

• 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.

• Collaborate with process development scientist to get trained and transfer new processes into cGMP manufacturing.

Minimum Requirements/Qualifications:

• Bachelor's degree in biotechnology, biology, engineering or related pharmaceutical science and 3+ years relevant cell processing experience (1+ years direct experience working with cell therapy autologous or allogenic programs) in Manufacturing

• Master's degree in chemistry, biotechnology, biology, engineering or related pharmaceutical science and 2+ years relevant cell processing experience (1+ years direct experience working with cell therapy autologous or allogenic programs) in Manufacturing

• Previous hands-on experience in a cGMP or clinically regulated environment is required.

• Knowledge of aseptic processing in ISO 5 biosafety cabinets strongly preferred.

• 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.

• Ability to work weekends when necessary.

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 life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we