Principal Manufacturing Scientist

4 weeks ago

Thousand Oaks, California, United States Takeda Pharmaceutical Company Ltd Full time
About the Role

The Principal Manufacturing Scientist will support the Manufacturing Sciences Department in Cell Culture and Purification manufacturing processes. This role oversees daily manufacturing support, inter-facility, and global process alignments/improvements initiatives of commercial and clinical manufacturing operations of a multi-product manufacturing plant.

Key Responsibilities
  • Lead technical and cross-functional teams to conduct technology transfer, process optimization, and investigations.
  • Lead Quality by Design exercise and documents, as well as prepare, approve, and execute study and validation protocols and reports.
  • Support as Subject Matter Expert manufacturing investigations, monitoring of process performance 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.
Requirements
  • 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.
About Takeda

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.

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