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Job Description

About the role:

Plan, develop improvement and compliance projects relating to assay method validation/remediation, and Analytical Instrument Qualification. Responsible for basic project management and documentation authoring (e.g. protocols and reports). Provide technical expertise investigation teams in troubleshooting/problem solving activities as applicable. Provide recommendations for decisions of test systems and results of moderate complexity. Self-led individual that works toward goals.

How you will contribute:

• Lead ongoing assay validation/remediation activities for Biochemistry and Microbiology Laboratory, guiding personnel and ensuring smooth operation across all shifts.

• Develop test procedures, protocols, reports, and documentation to support method and equipment validation and revisions.

• Guide Analytical Instrument Lifecycle projects including qualification, relocation, decommissioning, and risk assessments.

• Manage quality processes for change controls, deviations, and CAPAs, ensuring compliance and resolution.

• Author complex technical assessments to support investigations and problem-solving initiatives.

• Develop systems focusing on assay performance indicators, including trend analysis and data analytics.

• Lead process and product improvement projects through CAPA, QWT, and other methodologies, from data generation to report preparation.

• Support laboratory audit readiness efforts, ensuring compliance with FDA, Takeda, and other regulatory requirements.

What you bring to Takeda:

• Typically requires bachelors' degree in science, engineering, or other related technical field. Bachelor's Degree in Chemistry or Biological Science. 2+ years of related experienced. Leadership experience.

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. You may:

• In general, your work will be a combination of sedentary work, standing work, and walking around observing conditions in the facility.

• Must be able to lift, push, pull and carry up to 25 lbs.

• 20/20 near vision required (corrected as acceptable).

• Must be able to recognize and distinguish among the colors red, yellow, and blue.

• May work in a confined area.

• Some Clean Room and cool/hot storage conditions.

• 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.

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

• May work in a cold, hot or wet environment.

• May work multiple shifts, including weekends, or be asked to work supplemental hours.

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

• Inside working conditions.

• 5% travel as applicable.

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 t