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Senior Scientist - Formulation Chemist (Process Development)

Senior Scientist, Formulation Chemist (Process Development)

Novome is building genetically engineered microbial medicines (GEMMs) that perform defined activities in the human gut to treat chronic diseases. We have developed the first platform for controlled colonization of the gut with engineered therapeutic bacteria, and are applying this to multiple disease areas as well as expanding our platform capabilities. We are moving our lead program in secondary hyperoxaluria into Phase 1 clinical trials, and are actively progressing programs in IBS, IBD, and Immuno-oncology.

We are currently seeking a Senior Scientist to lead process development to advance the formulation strategy for our early-stage platform. This role will be cross functional, engaging with teams across research and development, process development, and manufacturing. A successful candidate will contribute to advancing formulations of live bacterial therapeutics and complex polysaccharides, and develop lyophilization cycles and processes to increase stability of live cell therapies. Previous experience with formulation development of microbes is desired. This person will serve as a liaison between R&D functions and process development, bridging the functional areas to ensure the development of processes, assays, and methods. This person will have a multi-faceted skillset and will be a strong individual contributor, while also having the experience to lead across teams.

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

Responsibilities

  • Develop the formulations functional area and identify core deliverables
  • Design an optimized lyophilization process for live cell therapies that is scalable, robust, and meets required standards for the manufacturing setting
  • Lead the design of experiments, execution of assays, synthesizing of data and presentations to leadership
  • Develop testing and characterization of degradation of lyophilized product under accelerated conditions and/or stressed environments
  • Develop and qualify analytical methods, SOPs, and other documentation that will be transferred to CMOs or into the quality environment
  • Review and author study reports, batch records, IND sections, and other necessary documents
  • Coordinate activities and contracts with CMOs and vendors
  • Engage in technology development to enable current and future process improvements

Key Qualifications

  • PhD in chemistry, physical chemistry, chemical engineering, or a related discipline
  • 3+ years of industry experience a plus
  • Deep understanding of process development, advancing drug candidates, and technology transfer
  • Proficiency with lyophilization, formulation, buffer and excipient selection
  • Experience with reviewing, authoring, and editing reports
  • Strong understanding of the quality environment and relevant 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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