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Scientist / Senior Scientist - Process Development

Scientist / Senior Scientist - Process Development

Novome is building genetically engineered microbial medicines (GEMMs) that perform defined activities in the human gut to treat chronic diseases. We’ve developed the first platform for controlled colonization of the gut with engineered therapeutic bacteria. Our recent $33M Series A funding will bring our lead program in hyperoxaluria into the clinic and expand our platform to additional disease areas.

We are currently seeking an experienced professional to serve as a leader in process development to advance our early-stage pipeline into the preclinical setting. This role will be cross functional, engaging with teams across research and development, process development, and manufacturing. A successful candidate will contribute to advancing lead strains, small and large-scale fermentation, generation of cell banks, process optimization, method development, analytical testing, and related CMC activities. Previous experience with fermentation of microbes is required. S/he will serve as a liaison between R&D functions and process development, bridging the functional areas to ensure the development of robust strains, assays, methods, and culture processes. This person will have a multi-faceted skillset, and will not be afraid to be an individual contributor while also having the experience to lead a team.

Knowledge of GMP environment and previous experience working with CMO is highly desirable. Prior experience developing a microbial process and transferring that process to either the manufacturing or quality setting is desirable. In addition, prior experience advancing an asset to the clinical setting and an understanding of CMC deliverables will be a valuable attribute.

Responsibilities

  • Develop the process development functional area and identify core deliverables
  • Design an optimized fermentation process that is scalable, robust, and meets the standards for the manufacturing setting
  • Lead the design of experiments, execution of assays, synthesizing of data and presentations to leadership
  • Develop and qualify analytical methods, SOPs, and other documentation that will be transferred into the quality environment
  • Reviewing and authoring study reports, batch records, IND sections, and other necessary documents
  • Coordinating activities with CMOs and vendors, and familiarity with joint contracts
  • Engaging in technology development to enable current and future process improvements

Key Qualifications

  • PhD in microbiology, bioengineering, biochemistry, molecular biology, or a related discipline
  • 3+ years of industry experience a plus
  • Deep understanding of process development, advancing drug candidates, and technology transfer
  • Proficiency with fermentation, cryopreservation, lyophilization, and formulation is preferred
  • Experience with reviewing, authoring, and editing CMC submissions
  • Strong understanding of the quality environment, GMPs

To apply, please visit https://novomebiotechnologies.applytojob.com/apply/

Novome Biotechnologies, Inc. is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.

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