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Job Description

About the Role:

This position reports to the Head of Manufacturing Sciences. This position is responsible for providing process support to the manufacturing groups at the Round Lake Site. The Manufacturing Sciences team is responsible for investigating and troubleshooting adverse events within the manufacturing facility area by assisting our quality and manufacturing partners in troubleshooting issues, supporting regulatory inspections by defending technical decisions to regulatory agencies and maintaining process compliance. The team develops scientific and engineering insight and knowledge on the fill-finish operations resident in the site and owns the specifications for the product and intermediaries. Finally, the team owns the site yield metric, and the yield improvement projects for the site.

How you will Contribute:

• Lead and support teams to support complex technical problems that are critical to Deviations andCAPA’s.

• Develop and disseminate technical insight and knowledge in fill-finish operations and associated

• exceptions, through definition of technical projects and subsequent planning and execution.

• Develop expertise in effect of filling/finishing operations on biologics.

• Provide technical reports in support of Process Validation

• Act as liaison with Regulatory on projects requiring regulatory submissions.

• Support the site during inspections as one of the technical experts.

• Lead and drive yield improvement projects in support of higher yields. Track and trend yields and report on key metrics.

• Interface with Manufacturing to help drive key metrics.

• Mentor junior team members supervise interns or rotation of Operation

• Development Program participants.

What you bring to Takeda:

• Typically requires a Bachelor’s degree in science, engineering or other related technical field. 4+ years of related experience.

• Advanced degrees (M.S. and/or Ph.D.) are desired, as well as experience with fill/finish operations preferred.

• Must be proficient in written and oral English

• Hands-on capability in failure and root cause analysis

• Working knowledge of DMAIC methodology and experience running projects employing the method

• Knowledge of engineering principles and biochemistry. Specifically, in three out of seven areas below:

• Flexible container design, analysis, manufacturing (heat sealing) and troubleshooting

• Materials expertise in thermoplastic flexible multi-layer containers, working knowledgecharacterization methods,

• Biochemistry of Albumin - Protein aggregation and denaturation. Fluid dynamics of filling

• Mechanical design (SolidWorks, Fixture/Jig building)

• Process Engineering and Lifecycle Management

• Data Visualization (Tableau or Power BI) and/or Machine Learning Tools

• Proficiency in statistical methods to analyze heterogenous data (from batch records), develop experimental plans and characterize existing complex processes. Minitab or JMP experience is desired.

• Ability to perform experiments in a laboratory and Pilot Plant setting.

• Excellent interpersonal skills.

• Excellent communication skills.

• Greenbelt certification desired

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:

• Must be able to work in controlled environments requiring special gowning.

• Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.

• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

• Must be able to work multiple shifts, including weekends as needed.

• May be required to work in a confined area.

• Requires flexibility to complete activities during off shift hours and/or conduct activities in support of different shifts as needed.

• Willing to travel.

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.

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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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