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Job Description

About the role:

You will report to the Manufacturing Sciences Manager. The Round Lake Site for Takeda produces the portfolio of Albumin filled into flexible containers (IV bags) You will provide material selection, characterization, trouble-shooting and technical support for the multi-layered film, for the custom molded port, for the container closure system and for the entire container system. The larger Manufacturing Sciences team develops scientific and engineering knowledge on the fill-finish operations resident in the site and owns the specifications for the product and intermediaries.

How you will contribute:

• Oversee container material related specifications and risk management activities for the site.
• Oversee the selection and manufacturing evolution of the container closure materials.
• Lead teams to support complex technical problems that are critical to Deviations and CAPA's, associated with the container system.
• Develop expertise in the characterization of particulate material and work with internal and external partners in their identification, risk assessment and mitigation.
• Develop expertise in filling/finishing operations for flexible container filled biologics.
• Communicate technical knowledge in fill-finish operations, through definition of technical projects and subsequent execution.
• Implement Risk Management activities related to the container and process failure modes and defects.
• Support the site during inspections as one of the technical experts.
• Communicate with Manufacturing to help guide metrics.
• Develop and implement, with team, current Container Closure Integrity Test (CCIT) methods.
• Must be proficient in written and oral English.
• Knowledge of polymer science principals. Specifically, in flexible container or injection molded component material selection and characterization.
• Demonstrated experience in application of industry standard characterization and experimental methods as related to the product material systems.
• Desire to become the Subject Matter Expert (SME) for effects of heat-sealing methods on the product materials.
• Desire to collaborate in implementation of current CCIT methods.
• Desire to become SME in failure and root cause analysis.
• Proficiency in statistical methods to analyze heterogeneous data (from batch records), develop experimental plans and characterize existing complex processes. Minitab experience.

What you bring to Takeda:

• Typically Requires: Bachelor's degree in polymer science, material science, polymer engineering or other related technical field. 4+ years of related experience.
• Advanced degrees (M.S. or Ph.D.) are desired, and experience with fill/finish operations.

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, you will have a combination of sedentary work, standing work, and walking around observing conditions or performing work in the facility.
• Must be able to carry up to 25lbs, lift up to 25lbs, push/pull up to 25lbs (with assistance of material handling equipment).
• During observations and inspections: Must be able to stand and/or walk for an extended period of time over an 8–12-hour shift between rooms and across the site.
• Indoor working conditions.
• General office environment with air conditioning and heating.
• Will work around moving equipment and machinery during observations.
• During observations and inspections: 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. No make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• During observations and inspections: May work in confined spaces/areas.
• May work in a cold, hot or wet environment.
• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Requires flexibility to complete activities during non-traditional business hours and conduct activities to support different shifts.
• Willing to travel. Travel required up to 20%.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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.

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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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