Sr. Scientist, Process Development (Upstream) - Irvine, CA

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Job description

Sr. Scientist, Process Development (Upstream) - Irvine, CA

Summary/Objective: The Senior Scientist will be responsible for complex programs related to viral vector production. He/she will support the group regarding upstream activities/initiatives.

Essential Functions: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

• Undertakes complex and multi-faceted client and innovation programs.
• Applies established platform approaches and utilize problem-solving skills to rapidly solve day to day experimental challenges
• Performs experiments at the bench and pilot scales, spanning all aspects of Upstream viral vector production processes
• Applies fundamental scientific and engineering principles to viral vector and protein production processes in order to support process development and process characterization, evaluate process improvements and resolve potential processing issues
• Communicates work through oral presentations and written documentation including technical reports and GMP documents to support regulatory filings
• Participates in cross-functional teams and interact with representatives from Process Development, Project Management, Manufacturing, and Quality to arrive at and implement viable / practical solutions to support clinical/commercial manufacturing
• Provides scientific technical support for technology transfer of processes to manufacturing
• Utilizes out-of-the-box thinking to contribute to technology development
• Utilizes design of experiments and statistical analysis of data
• Primary project contact with a client and must be articulate around the science and problem solving
• Supervises a team of junior scientists and research associates
• Manage timelines and coordinate resources with function heads to ensure project deliverables are achieved
• Perform other duties as assigned

Required Education and Experience:

• MS or PhD (preferred) in Molecular Biology, biochemistry, chemical/biochemical engineering or related disciplines
• 5 years of in-depth technical experience in production process development for viral vectors and/or large molecules from mammalian and insect cells.
• Solid knowledge and experiences in production process engineering and process scale-up/scale-down design is essential.
• Leadership experience with proven capability as a successful leader in a strategic multi-functional environment, highly skilled in leading change and people agility.
• Strong business acumen and critical thinking.
• Proven experience in process characterization and validation.
• Hands on experiences with technology transfer of manufacturing process.
• Knowledge of cGMP's, regulatory guidelines, validation practices, and other relevant regulatory requirements.
• Excellent interpersonal communication and presentation skills

For immediate consideration apply today!

Questions? Please reach out to Dustin at

#TJP2021_SPEC

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

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