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Spark Therapeutics - Philadelphia, PA

posted 2 months ago

Full-time - Mid Level
Philadelphia, PA
Ambulatory Health Care Services

About the position

The Upstream Process Development Scientist at Spark Therapeutics will play a crucial role in the development and optimization of processes for recombinant adeno-associated viral vector (rAAV) production. This position involves hands-on work with cell culture bioreactors, focusing on process development, troubleshooting, and technology transfer to manufacturing sites. The scientist will be responsible for conducting experiments, analyzing results, and authoring technical documentation, contributing to the advancement of gene therapy solutions.

Responsibilities

  • Perform experiments in the development, optimization, characterization, and scale-up of rAAV production processes in suspension cell culture systems.
  • Conduct rAAV production studies in shake flasks and stirred tank bioreactors from AMBR to commercial pilot scale.
  • Assist in addressing production process challenges by applying cross-functional knowledge.
  • Analyze and interpret experimental results; suggest changes or additional experiments to improve robustness and reproducibility.
  • Participate in discussions regarding troubleshooting of production processes and perform supporting studies as needed.
  • Contribute to the evaluation and implementation of new technology development.
  • Participate in Technology Transfer from process development to manufacturing sites; assist in training manufacturing staff as needed.
  • Author and execute protocols, assemble data, and draft appropriate technical documentation, including SOPs and Process Development Reports.
  • Maintain an accurate laboratory notebook following ALCOA+ principles.
  • Participate on Pipeline and/or Technology Platform project teams as a contributing member.

Requirements

  • Ph.D. in a relevant scientific discipline or a B.S./M.S. with 3+ years of relevant scientific and/or technical experience in the Bioprocessing field.
  • Hands-on experience in upstream process development with aseptic suspension cell culture methods in shake flasks and stirred tank bioreactors.
  • Adept technical writing skills with experience authoring/reviewing technical documentation (protocols, reports, SOPs, etc.).
  • Experience in Technology Transfer of suspension cell culture stirred tank bioreactor production processes from Process Development to cGMP receiving entities is preferred.
  • Experience with ambr250ht, ambr15, and/or BioFlo bench-scale bioreactors is preferred.
  • Familiarity with statistical design/analysis software and digital proficiency is a plus.

Nice-to-haves

  • Experience with development and process optimization in bioreactors is a plus.
  • Familiarity with bioreactor harvest operations including filtration is a plus.
  • Familiarity with AAV or viral vector production is preferred.

Benefits

  • Competitive salary range of $87,300 - $130,900 per year.
  • Opportunities for professional development and training.
  • Participation in innovative projects in gene therapy.
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