Sr. Scientist - Upstream Process Development

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Rockville, MD

Industry: Biotech/Pharma

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8 - 10 years

Posted 277 days ago

This job is no longer available.

Mid-Size Biologics company in the Rockville, MD area is looking to add a Sr. Scientist, Process Development (Upstream) to their team! Will act as the technical lead for the development and optimization of novel cell culture and bioreactor processes for biologics production. Responsibilities range from cell line selection, Bioreactor process development, process scale-up, characterization studies, robustness studies, and authoring transfer documents for tech-transfer to the clinical manufacturing site(s).

This position requires hands-on execution of process optimization, cell culture media/feeds screening, and improvements, along with process characterization of cell culture production processes that can be transferred to the Manufacturing group as well as to external collaborators. Furthermore, this individual is expected to work independently on assigned tasks/projects, mentor junior associates, and provide insight to improve processes, and communicate results to the CMC team. 

Responsibilities include:

  • Develops scalable, robust, high yielding, and economically viable cell culture processes using miniature, bench-scale, and larger disposable bioreactors in the laboratory setting for the production of biologics
  • Performs hands-on experiments to develop feed strategies using chemically defined medium and feeds
  • Designs scientifically rigorous experiments using statistical DoE where applicable
  • Executes experiments, analyzes and interprets data, to make process improvements, and further design next studies
  • Executes process monitoring and control strategies for robust process design
  • Ensures scalability of unit operations during process development
  • Collaborates and coordinates material needs with colleagues from research, downstream, analytical, and formulation groups
  • Manages, and trains junior associates on procedures and processes in the lab
  • Provides person-in-plant support for cGMP manufacturing of pre-clinical and clinical study materials
  • Authors Standard Operating Procedures, technical reports, process descriptions, including data interpretation and procedures suitable for inclusion in IND, BLA, or equivalent regulatory submission
  • Supports the execution of start-up, commissioning, and maintenance of equipment and processes

Requirements:

  • Ph.D. with5+ years OR MSDegreewith8+ year of industry, upstream process development experiencewithin biologics
  • Hands-on experiencewith mammalian and/or insect cell culture, aseptic techniques, understanding of biochemicalengineering concepts, and biochemical pathways
  • Significant experience in developing and improving scalable fed-batch, transfection, and perfusion upstream processes in PD setting
  • Familiar with Bioreactor Scale-up concepts and have a proven record for scaling-up processes to disposable/stainless bioreactors
  • Ability to use Design of Experiments in JMP, Design Expert, or other for statistical experimental design, and data analysis
  • Ability to operate disposable Bioreactors at 10L, 50L, and 200L scales

$101K - $134K