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Job Description

About the role:

The Manufacturing Scientist II will support the Manufacturing Sciences (MS) Department specifically in Cell Culture and Purification (Drug Substance) manufacturing processes. You will manage MS daily manufacturing support, inter-facility, and global process alignments/improvements projects of commercial and clinical manufacturing operations of a multi-product manufacturing plant. You will directly support manufacturing operation process improvements and technical transfers.

How you will contribute:

• Provide support to technical and teams to conduct technology transfer, process optimization, and investigations.

• Prepare, and complete risk assessments, manufacturing sciences studies and/or validation protocols and reports, such as Validation Master Plans, Process Validation Lifecycle (mixing validation, process/hold times, membrane/resin lifecycle) and Material qualification to support capital projects, process improvement, technology transfer, and material changes activities.

• Support manufacturing investigations, monitoring process performance to meet quality, yield, capacity, and timelines, troubleshooting GMP equipment and processes, providing technical input for SOPs and production records.

• Provide support to audits, change controls, and regulatory submissions.

What you bring to Takeda:

• Bachelor's degree in a scientific discipline with at least 3+ years of experience, MS with at least 1+ years.

• Basic knowledge of Cell Culture, Purification, process scale-up, troubleshooting, process technical evaluations, statistical analysis, and experimental design.

• Basic knowledge of laboratory and pharmaceutical production equipment including bioreactors, chromatography process, ultrafiltration, diafiltration, sterile filtration, process tanks, and CIP/SIP systems.

• Experience preparing and building study protocols to design & undertake quality scientific experimentation for purpose of troubleshooting, scale-up, or process optimization.

• Experience with lifecycle process validation such as mixing validation, process/hold times, resin/membrane lifecycle

• Experience interpreting results of experiments and validation activities and making recommendations for process improvements that reflect understanding of regulatory requirements, our goals, and possible effects.

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:

• 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 artificial fingernails while in the manufacturing environment.

• Work in a cold, hot storage, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

• Normal office environment.

• May require availability outside of business hours.

• The overall physical exertion of this position is medium work.

• May be required to lift to 35 pounds when handling samples.

• May be required to work in controlled of clean room environments requiring special gowning

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 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.

#GMSGQ #ZR1 #LI-MA1

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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