Specialist, Sample Management and Testing - Cell Therapies

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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 Specialist, Sample Management and Testing, Cell Therapy in our Cambridge office.

As a Specialist, working on the QC Analytics team within Cell Therapy Manufacturing organization is responsible for sample management and testing to support the manufacturing of investigational medicinal products (IMP) utilized in Takeda clinical studies. You will assist the QC analytical group in sample, material and data management while following cGMP, environmental health and safety guidelines and any other related regulations which could apply.                              

• Perform incoming component/raw material inspection/testing, in-process testing, and product release testing to support the manufacturing of cell therapy drug products manufactured in the internal GMP facility.

• Perform sample management and shipment of samples to the contract laboratories. 

• Assist in the digital transformation of the QC laboratory.

• Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.

• This position is responsible for assisting in activities for the QC laboratory from ordering to inventory management, to raw material and sample management, to equipment Calibration, cleaning and maintenance.

• The position will be assisting with external sample management and shipment.

• Assist in data trending and report writing as assigned.

• Assist in stability testing as needed.

• Assist in the investigation into any non-conformance, OOS, OOT, instrument malfunction, accident or other abnormal occurrence per SOPs.

• Bachelor’s degree (or equivalent experience) in biotechnology, biology, chemistry, pharmacy, engineering or related pharmaceutical science and 1+ years relevant industry experience or Master’s degree (or equivalent experience) in biotechnology, biology, chemistry, pharmacy, engineering, or related pharmaceutical science.

• Experience working in a cell therapy GMP laboratory is essential

• Basic 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.

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 do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.