Job Description

About the role:

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

This is an on-site role that reports to the Head of Manufacturing Sciences.

How you will contribute:

Lead technical and cross-functional teams to conduct technology transfer, process optimization, and investigations.
Lead Quality by Design exercise and documents, (i.e. process FMEAs, risk assessments) as well as prepare, approve, and execute study and validation protocols and reports.
Support as Subject Matter Expert manufacturing investigations, monitoring of process performance (Lifecycle Process Validation Stage 3 Continuous Process Verification) to meet quality, yield, capacity, and timelines, troubleshooting GMP equipment and processes, providing technical input for SOPs and production records.
Collaborate with Global partners to support common initiatives and strategies. Be the subject matter expert for audits, change controls, and regulatory submissions.
Assist and own Validation Master Plans, Process Validation and Material qualification activities to support capital projects, process improvement, technology transfer, and material changes.
May perform other duties as assigned.

What you bring to Takeda:

Bachelor's degree in a scientific discipline with at least 10 years of relevant experience, MS with at least 8 years, or PhD with at least 4 to 6 years of relevant experience.
Proficient knowledge of Cell Culture, Purification, process scale-up, troubleshooting, and process technical evaluations. Proficiency in statistical analysis and experimental design, knowledge of laboratory and pharmaceutical production equipment including bioreactors, chromatography processes, ultrafiltration, diafiltration, sterile filtration, process tanks, and CIP/SIP systems.
Proficient expertise performing Product Impact Assessments to support process deviations, generating risk assessment to support change controls and qualification activities, preparing and executing study protocols to design and undertake quality scientific experimentation for purpose of troubleshooting, scale-up, or process optimization.
Proficient expertise interpreting results of experiments and making recommendations for process improvements that reflect understanding of regulatory requirements, business objectives, and cost implications. Proficiency leading projects, tech transfer, and people to support manufacturing activities.
Knowledge of basic chemical and biological safety procedures, regulatory agency requirements and submission write up for the bio pharma industry, experience participating in regulatory compliance audits.

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:

The overall physical exertion of this position is medium work.
May be required to lift to 35 pounds when handling samples.
Normal office environment.
Pace may be fast and job completion demands may be high.
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.
Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
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.
May require availability outside of business hours.

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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