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 preferred. This position works closely with internal and external stakeholders to deliver technical documents such as reports, protocol, and data reviews.This candidate will help 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, 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.
- 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/or 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
- B.S in chemical engineering, microbiology, biochemistry, biotechnology, biology, or related field.2-5 years of experience in biopharmaceutical industry is preferred.
- Experience in plasmid and/or novel nucleic acid processes and technologies
- Experience in molecular biology, upstream and downstream bioprocessing is preferred
- Ability to design experiments, follow procedures with attention to detail, and successfully execute experiments at the bench
- Demonstrated ability to maintain detailed execution records and perform data analysis
- Knowledge or experience with viral vector manufacturing in the biotech industry
- Previous microbial fermentation and downstream purification experience is preferred
- Strong communication skills (e.g., clear and concise) and a team player
- Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
- Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
- Takes ownership of the assigned project, consulting with management and peers
- Able to understand and interpret data/information and its practical application