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Job Description

This position reports to Weekend Night (E) shift. This shift schedule is Saturday and Sunday 10:00 PM to 10:00 AM, plus a third day during the week. This shift requires working on all company designated holidays. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.

About the role:

Conduct biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw material through finished goods including at a minimum; in-process, final container, stability and critical systems testing. Ensure the daily operations of assigned functional area are met through scheduling, troubleshooting, and coaching. Must participate and improve completion of improvement projects and responsible milestones.

How you will contribute:

Essential duties:

• Conduct biological, chemical and physical analyses on raw materials, stability, in-process samples and final products, and samples collected from systems monitoring programs, following controlled test procedures. Work under Supervision.

• Use laboratory instrumentation and computer systems to collect and record data. May perform advanced assays requiring precise analytical skills and understanding of biological and chemical principles.

• Perform review of test data with application of GDP.

• Complete all testing, including special project / protocol testing promptly.

• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Ensure data integrity and regulatory compliance is maintained in assigned area and/or system.

• Some familiarity with product specifications, process reference files, code of federal regulations, and compendia requirements.

• Use Global LIMS or other computerized systems for entering and approving test results.

• Contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, generate cost savings, improve quality, and provide new product support.

• Ensure the laboratory area is maintained in a GMP state while following all EHS and 5S guidelines. Will do laboratory walk through to ensure area is suitable for hand off to oncoming shifts.

• Perform equipment maintenance and calibrations. May be the subject matter expert on assigned equipment.

• Apply Lean principles such as 5S throughout daily work activities.

• Ensure personal training requirements are met and that training records are current.

• May perform microbial and particulate monitoring of clean rooms throughout the Manufacturing Facility for qualification purposes.

• May perform removal of hazardous waste.

• Other duties as assigned by departmental management.

What you bring to Takeda:

Qualifications

• Must have basic understanding of laboratory instrumentation and chemical handling.

• Working knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs and USP, JP, EP procedures.

Education and experience:

Typically requires Bachelor's Degree in Science-Chemistry or Biological Science. 2+ years of experience.

Physical Demands:

• 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 work in controlled environments requiring special gowning. Will follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. This may include additional hearing protection for loud areas.

• No contact lenses may be worn in the work environment. No make-up, jewelry, nail polish or artificial nails may be worn in the work environment when applicable.

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

• May enter a cold, wet environment and climb stairs or ladders to retrieve samples.

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.

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.

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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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