Downstream Process Development Engineer

Cambridge, Massachusetts, United States Full-time

Evelo Biosciences is seeking a Downstream Process Development Engineer to join our growing team.

Evelo Biosciences is a fast-paced company discovering drugs based on the previously unexplored biology of the interactions between the gut and the rest of the body: gut-body network.  We are developing a new class of medicines that could change the standard of care of many major diseases for the great benefit of large numbers of patients worldwide.  These medicines are designed to act on the gut-body network – monoclonal microbials. They are single strains of human commensal microbes which use naturally evolved pharmacology to work in the gut for effects throughout the body, providing effective, convenient and safe medicines to address the unmet needs of huge numbers of patients.

We are seeking a dedicated Downstream Process Development Engineer who is interested in joining a highly dynamic and intellectually challenging team. This position will offer a tremendous opportunity to gain experience in design and scale-up of novel processes. In addition, this role will engage in critical collaborations with our manufacturing, microbiology, immunology, and bioinformatics teams. The successful candidate will be innovative, thrive in an intense and dynamic environment, and use his/her creative and imaginative problem-solving skills to help bring new products to patients.

Primary Responsibilities:

  • Lead downstream laboratory and pilot scale studies to support process development, optimization, characterization and scale up.
  • Performed assays on products, process intermediates.
  • Contributes to the evaluation of novel platform technologies that can be applied across multiple programs.
  • Support tech transfer to both internal and external clinical manufacturing partners.
  • Review GMP batch records, SOPs, raw material specifications.
  • Author technical development report, tech transfer documents.
  • Author regulatory filing documents such as IND, IMPD, BLA.
  • Maintain lab organization and records.

Desired Skills & Qualifications:

  • Strong knowledge in harvesting, UF/DF, chromatography technologies. 
  • Strong knowledge of lyophilization process development including cryoprotectant and freeze-drying cycle design is a plus.
  • Industry experiences with tech transfer and process scaling up in related to downstream purification process.
  • Strong planning and communication skills in a dynamic project environment. Technical support experiences in CMO executed projects is a plus. 
  • Goal oriented team player with excellent communication skills.

Education & Experience:

  • Ph.D. with more than 4 years, or M.S with over 8 years or B.S with over 10 years direct biotech industry experience and successful track record.  Engineering degree preferred.
  • Product and purification process development experience in the biotechnology/pharmaceutical industry with practical expertise around scale-up, tech transfer and manufacturing support to large scale GMP operations is required.
  • Familiarity with the operation of large scale purification equipment for chromatographic and filtration unit operations is required.
  • Demonstrated understanding of GMP regulation and FDA/EMA guidance on manufacturing process for biologics.
  • Proven track record of large scale process implementation is required.

 

About Evelo

Evelo Biosciences, Inc. is a clinical-stage biotechnology company developing a new modality of medicine, monoclonal microbials, which are designed to act on the gut-body network. Evelo’s product candidates are orally-delivered, single strains of microbes, selected for their defined pharmacological properties. They are intended to modulate systemic immunology and biology by acting on multiple naturally evolved biological pathways through the gut-body network. Evelo believes that monoclonal microbials have the potential to be broadly applicable across many diseases including immunoinflammatory, cancer, autoimmune, metabolic, neurological and neuroinflammatory diseases.

Evelo currently has three product candidates, EDP1066 and EDP1815 for the treatment of inflammatory diseases and EDP1503 for the treatment of cancer, for which ten clinical readouts are expected during 2019 and 2020. Evelo is also advancing additional candidates through preclinical development in other disease areas.

For more information, please visit www.evelobio.com.

Apply for this opening at http://evelobio.recruiterbox.com/jobs/fk01n9q?apply=true