By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

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