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Job Description

Job Title: Analyst, Cell Therapies QC Microbiology

Location: Cambridge, MA

About the role:

You will report to the Associate Director Cell Therapy Microbiology QC. The Analyst, Cell Therapies QC Microbiology ensures the performance of the environmental monitoring program and associated qualification programs regarding manufacturing of cell therapy investigational medicinal products used in Takeda clinical studies. You will coordinate personnel sampling and certification in a cGMP cleanroom setting (Grade A-C). The Analyst, Cell Therapies QC Microbiology conducts routine environmental monitoring and microbiological testing (in-house and outsourced) to support a clinical-stage cell therapy manufacturing facility.

How you will contribute:

• Perform environmental monitoring [viable particulate (air, settle plates, contact plates) and non-viable particulate], in-process testing, and release testing related to microbiology to support the manufacturing of clinical-stage cell therapy drug products at an internal GMP facility.
• Ensure that monitoring and testing are performed on time and.
• Perform gowning qualifications for personnel needing access to the internal GMP facility.
• Prepare reports, perform trend analysis, maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
• Support the investigation into any non-conformance, OOS, OOT, instrument malfunction, accident or other abnormal occurrence per SOPs.
• Support maintenance, calibration and cleaning of environmental/microbiological equipment and instruments.
• Support diverse qualification activities (facility, cleaning, software).
• Keep the Microbiology lab clean, safe and tidy all the times.
• Author, edit, and review SOPs, job aids, reports as assigned.
• Work and collaboratively with team members from QA, QC, production, facility and development.

What you bring to Takeda:

• Bachelor's Degree in Microbiology or another relevant field
• 1+ years' experience in GMP/Microbiology/QC

Abilities/Experience:

• Experience performing environmental monitoring in GMP cleanrooms (Grade A-C)
• Experience gowning qualification and aseptic techniques
• Microbiology knowledge and practical experience of microbiology testing
• Experience writing and reviewing SOPs
• Experience using a LIMS
• Experience working in a laboratory
• Analyze common scientific and technical documents/information
• Present information to management, internal groups and team members.

ADDITIONAL INFORMATION

• You will support biopharmaceutical production operations therefore the work environment may include exposure to production and cell processing facilities and analytical laboratories (this list is not exhaustive).

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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