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Job Description

About the Role:

Assist in the development of lab test methods on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Shire manufacturing facilities.

How you will Contribute:

• Assist in the development of lab test methods on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Shire manufacturing facilities.

• Work under minimum supervision.

• Assist with the installation and validation of sophisticated laboratory instrumentation and computer systems to collect and record data.

• Perform advanced assays requiring precise analytical skills and understanding of microbiology and chemistry principles.

• Complete all testing, including special project / protocol testing in a timely and appropriate manner.

• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.

• Investigate deviations and write exception documents.

• Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.

• Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.

• Perform equipment maintenance and calibrations as required.

What you bring to Takeda:

• Bachelor’s Degree in Chemistry, or Biological Science with Analytical Chemistry Microbiology Laboratory coursework and 0-3 years’ experience
• Proficient in wet and instrumental methods of analyses.
• Advanced laboratory skills and basic knowledge of statistical method.
• Strong technical problem solving skills
• Ability to handle multiple tasks concurrently, and in a timely fashion.
• Must communicate effectively (verbal and written) with supervisors and peers.
• Must demonstrate effectiveness in ability to train others
• Knowledge of most laboratory equipment including but not limited to autoclaves, incubators, analytical equipment
• Must be proficient in a variety of mathematical operations and calculations and be able to work with both the metric and US standards of measurement.
• Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
• Knowledge of basic chemical and biological safety procedures.
• Good computer skills, knowledge of Microsoft Word, Excel and Powerpoint.

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, and buffers and Celite that may require respiratory protection.

• Combination of sedentary work and walking around observing conditions in the facility.

• Able to lift, push, pull and ca