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Job Description

About the Role:

Fractionation GMP Lead and Support position is responsible for implementing and supervising daily activities associated with execution of GMP Facility Cleaning to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (GMPs), environmental, health, and safety (EHS) guidelines, and any other regulations that apply.  May monitor and control labor resources.

How you will Contribute:

• Supervise the daily manufacturing operations in an area.  Maintain (audit, refine, improve) equipment and processes within this area.

• Provide a positive and equitable working environment emphasizing respect, responsiveness, and results.

• Support and emphasize the Safety and Quality commitments of the department.  Make decisions concerning these commitments within the area.

• Ability to utilize resources and raw materials in the most efficient and productive manner possible.

• Primary point of contact and subject matter expert for facility cleaning.

• Identify/prioritize/provide resources in an aera to assist the Manager to meet the annual operational plan and budgetary commitments.

• Facilitate and verify appropriate training for employees in the area (including but not limited to GMP, job skills, safety).

• Ensure compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements, as required.

• Commit to employee feedback and developmental process – support Talent Management goals, conduct recognition and disciplinary action for employees, facilitate employee representation throughout the organization.

• Submit and/or maintain and distribute reports related to attendance, labor, efficiency, safety, scrap, and others as needed.

• Ability to utilize resources and raw materials in the most efficient and productive manner.

What you bring to Takeda:

• Requires a bachelor’s degree, preferably in science, engineering, or another related technical field.  3+ years of related experience with 1+ years in a supervisor role.

• Demonstrate interpersonal and leadership skills, with ability to interface well with other departments and lead effectively and efficiency in a team environment

• Ability to manage multiple priorities in a manufacturing plant setting

• Strong professional writing skills and ability to prepare technical reports

• Ability to understand GMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry

• Strong assessment and troubleshooting skills

• Good computer skills

• Interact with all levels of personnel to analyze and solve problems related to manufacturing, quality, documentation, and personnel issues

• Work in and facilitate a team-oriented environment

• Collect and analyze data and information to determine paths for process improvement and potential root cause/corrective actions in the case of exceptions.

• Ability to respond to detailed inquiries and present information to groups and senior management

• May be required to supervise multiple groups

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:

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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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