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Principal Scientist: AAV Process Development

Employer
EPM Scientific
Location
San Francisco, CA
Closing date
May 15, 2022

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Sector
Science
Organization Type
Corporate
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Overview: This individual will be responsible for complex programs related to viral vector production. They will support the group regarding upstream responsibilities.

Essential Functions:
  • Executes multi-faceted and sophisticated client and innovation programs.
  • Quickly solves day-to-day experimental difficulties using established platform methodologies and problem-solving skills.
  • Conducts tests on a bench and pilot scale, encompassing all areas of viral vector upstream production.
  • Supports process development and characterization, evaluates process improvements, and resolves potential processing concerns by applying fundamental scientific and engineering principles to viral vector and protein manufacturing processes.
  • Supports regulatory submissions with oral presentations and written material, including technical reports and GMP documents.
  • Works in cross-functional teams with representatives from Process Development, Project Management, Manufacturing, and Quality to develop and implement feasible / practical clinical/commercial manufacturing solutions.
  • Provides scientific and technical support for the transfer of processes from development to production.
  • Contributes to technology development by thinking outside the box.
  • 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 group of junior scientists and research assistants.
  • Ensure project deliverables are met by managing timeframes and coordinating resources with function heads.


Required Education & Experience:
  • PhD in Molecular Biology, Biochemistry, Chemical/Biochemical Engineering, or a similar field with at least 5 years of in-depth technical experience in the development of production processes for viral vectors and large molecules from mammalian and insect cells.
  • A solid understanding of production process engineering and process scale-up/scale-down design is essential. Leadership expertise as a successful leader in a strategic multifunctional setting, with a strong understanding of implementing change and people agility.
  • Excellent business judgment and critical thinking skills.
  • Proven process characterization and validation experience.
  • Practical experience with manufacturing process technology transfer.
  • CGMPs, regulatory guidelines, validation processes, and other applicable regulatory requirements are all knowledgeable.
  • Outstanding interpersonal communication and presenting abilities
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