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Job Description

About the Role:

As a Quality Control (QC) Supervisor at Takeda, you will lead daily QC laboratory operations with a strong focus on microbiological testing, compliance, and process excellence. You will play a critical role in ensuring product integrity through method execution, investigations, and project leadership—directly supporting Takeda’s mission to deliver high-quality therapies to patients. This role will require hands-on microbiology expertise, method troubleshooting, and leadership in regulatory environments.

How you will Contribute:

• Oversee and execute routine and complex laboratory testing to support manufacturing operations, validation studies, and batch release—especially in microbiology.

• Perform and support microbiological methods such as:

  • Environmental Monitoring (EM)

  • Bacterial Endotoxin Testing (BET/LAL)

  • Sterility Testing

  • Water Testing and Sampling

  • Microbial Identification using Vitek and MALDI-TOF technologies

• Lead inventory control for laboratory reagents and materials, ensuring accurate documentation and stock levels.

• Conduct quality audits and participate in internal/external inspection readiness activities.

• Review and trend analytical data to monitor lab performance and product quality.

• Drive and support deviation investigations and implement corrective and preventive actions (CAPAs).

• Troubleshoot analytical methods and lab equipment with a focus on efficiency and compliance.

• Train and mentor junior analysts; provide performance guidance aligned with GMP expectations.

• Actively contribute to SOP revisions, lab process improvements, and cross-functional initiatives.

• Perform product testing using additional analytical methods including qPCR, SDS-PAGE Silver, Potency, and Compendial techniques.

• Apply principles of Good Manufacturing Practices (GMP) with growing independence.

• Support regulatory inspections and documentation practices per global quality standards.

What you bring to Takeda:

• Bachelor’s degree in Microbiology, Biology, Chemistry, or related technical field.

• 4+ years of hands-on experience in a QC laboratory, preferably within a pharmaceutical or similarly regulated industry.

• Strong background in microbiology with direct experience in sterility, endotoxin, water testing, and microbial identification.

• Proven ability to lead or coach team members, with experience in inventory management, investigations, and method troubleshooting.

• Familiarity with LIMS, data integrity requirements, and analytical instrumentation.

• Detail-oriented, organized, and collaborative with a proactive approach to problem-solving.

• Comfortable working in a fast-paced environment with shifting priorities.

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:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

• 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.

Shift Requirements and Associated Compensation:

Swing Shift

Monday – Friday

2:00 PM – 10:30 PM

Base Salary + 8% Shift Allowance

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