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Senior Scientist

King of Prussia, PA, US
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Summary

This role is responsible for planning, performing, analyzing, summarizing, reporting, and presenting experimental results related microbial fermentation and purification process development.

The ideal candidate will help design and startup a nucleic acid process development laboratory to support plasmid DNA production and mRNA synthesis. The scientist will develop a platform microbial fermentation process and subsequent downstream purification at both the laboratory and pilot scale. Experience in Microbial Fermentation Upstream and/or Purification Process development and optimization is a requirement.

This position works closely with internal and external stakeholders to deliver technical documents such as reports, protocol, and data reviews. The primary responsibility of this candidate is to develop a scalable end to end plasmid production platform. The scientist will also collaborate with both external and internal stakeholders to support ancillary activities such as analytical testing, cell banking, process scaleup, and technical transfer.

In addition to the technical skills required (plasmid process development, scale-up, and production), this role authors and reviews technical protocols and reports, drafts batch records and SOPs. The ideal candidate will successfully demonstrate upstream and downstream process development, scaleup, and analytics. Personal attributes including independent thinking, having a self-starter mindset, and strong collaboration skills are required. The final level of this position will be set according to candidate experience and qualifications.

Responsibilities

  • Designs and implements microbial strategies for upstream and downstream process development
  • Hands-on work in the developing, executing, and optimizing of upstream (fermentation, scale-up, characterization) and downstream (centrifugation, chromatography, and tangential flow filtration) unit operations for plasmid production
  • Support technology transfer into GMP manufacturing
  • Works closely with external partners on appropriate process and characterization studies to enable manufacturing
  • Authors and reviews development and process protocols, reports, and batch records
  • Supports analytical method development, qualification, transfer, and associated protocols/reports as needed
  • Assists with product quality attribute assessment and scoring to identify critical quality attributes (CQA)
  • Supports fermentation upstream and/or downstream process development activities
  • Traditional hours are expected, but will require occasional night, holiday, or weekend work in accordance with laboratory schedule
  • Potential responsibility to lead a small team

Qualifications

  • PhD in chemical engineering, microbiology, biochemistry, biotechnology, biology, or related field with 6+ years of industry-related experience; or M.S. with 8+ years; or BS with 10+ years of related industry experience
  • Ability to lead a cross-functional team to deliver on programs. Management experience is a plus but required
  • Experience in plasmid and novel nucleic acid processes and technologies
  • Experience in molecular biology, plasmid design and elements, and manufacturing processes, specifically, transformation, cell banking, production, purification, and storage
  • Knowledge and experience in fermentation, purification, and analytics
  • Proficient with large-scale (50L) fermentation and purification processes
  • Ability to design experiments, follow procedures with attention to detail, and successfully execute experiments at the bench
  • Project-management skills and ability to work successfully with contracting laboratories and manufacturing facilities
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
  • Demonstrated ability to maintain detailed execution records and perform data analysis
  • Knowledge or experience with viral vector manufacturing in the biotech industry
  • Expertise in microbial upstream and downstream process development, such as large-scale (50L) fermentation, depth filtration, tangential flow filtration, chromatography column purification
  • Experience with Design of Experiment (DOE)
  • Experience with microbial production, purification, and characterization
  • Strong communication skills (e.g., clear and concise) and a team player
  • Strong time and project management skills
  • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution

Senior Scientist

King of Prussia, PA, US
Apply Now >