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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 w