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Job Description

Job Title: Cell Therapy QA Manager

Location: Cambridge, MA

About the role:

The Cell Therapy QA Manager will report to the Director Cell Therapy Product Quality. You will lead and execute GMP QA operational activities associated with Takeda’s internal GMP cell therapies manufacturing facility. You will ensure compliance to regulations and Takeda procedures for internal cGMP manufacturing and testing of clinical-phase cell therapy programs. Directly manage the development of cGMP quality operational processes which support clinical-phase cell therapies. You will be specifically focused on GMP QA support for manufacturing operations.

How you will contribute:

• Employ GMP QA expertise and principles during the development, manufacturing, testing and disposition of clinical-phase cell therapies to ensure product quality and achieve our goals.
• Be a GMP QA subject matter expert responsible for well-documented and compliant resolution of deviations, investigations and CAPAs in field of responsibilities.
• Interact with quality team members and your team to support site goals, projects, and issue resolution.
• Manage internal quality improvement programs in responsible area: evaluate internal processes; suggest/design/implement improvements; create/revise relevant SOPs.
• Maintain knowledge of global regulatory requirements for cell therapy products and ensure compliance in field of responsibilities.
• Issue, review GMP documentation (e.g., batch records, SOPs, job aids) needed for internal manufacturing operations.
• Review batch record documentation, ensure compliance and accuracy, and make final disposition decision of cell therapy investigational material for use in Takeda-sponsored clinical studies.
• Participate in daily onsite quality guidance and collaborate throughout the company, using quality and manufacturing expertise to troubleshoot problems, interpret data, and applying risk-based approach for ongoing manufacturing operations and related quality events.
• Represent QA in site operations from thaw of starting material to drug product filling and labeling.

What you bring to Takeda:

• Bachelor’s Degree in Biology, Microbiology, Chemistry or related field. Master’s Degree in Microbiology, Biology, Chemistry or related field preferred
• 4+ years of experience in cGMP Quality Assurance
• Working knowledge of cell or gene therapy product testing, manufacturing or development

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:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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 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.

#GMSGQ  #ZR1  #LI-MA1

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:

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.

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Job Exempt