Formulation Scientist

Cambridge, Massachusetts, United States Full-time

Evelo Biosciences is seeking Formulation Scientists to join our dynamic and growing organization.

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 world-wide. 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.  As a member of the Evelo team, you will be a vital part of helping to shape Evelo’s vision: transforming therapies through a new modality of medicines.

We are seeking a talented and innovative Formulation Scientists who are interested in joining a highly dynamic and intellectually challenging team. These positions will offer a tremendous opportunity to gain experience in design and scale-up of formulations containing live biotherapeutics. Successful candidates will be innovative, thrive in an intense and dynamic environment, and use their creative and imaginative problem-solving skills to help bring new products to patients.

Primary Responsibilities:

  • Develop robust formulation and manufacturing processes for solid oral dosage forms for early/late-stage clinical development and commercial supply
  • Manage and collaborate with Contract Manufacturing Organizations (CMOs) to deliver GMP drug product for clinical development
  • Support tech transfer to both internal and external clinical manufacturing partners.
  • Review GMP batch records, draft SOPs and raw material specifications.
  • Author technical development reports, tech transfer documents.
  • Author regulatory filing documents such as IND, IMPD, BLA.
  • Setup/Maintain internal development lab and records.

 Desired Skills & Qualifications:

  • Hands-on experience developing formulations and manufacturing processes for various oral solid dosage forms (tablets, capsules, etc.), to meet phase appropriate requirements of the clinic and the commercial target product profiles.
  • Preformulation experience working with internal discovery teams.
  • Experience directing drug product development and manufacturing with CDMOs.
  • Industry experience with tech transfer and process scale up.
  • 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, flexibility, and ability to work in a fast-paced environment

Education & Experience:

  • D. in pharmaceutics, chemical engineering or related discipline with a minimum two plus years’ experience (or MS with at least 5 years’ experience) developing small molecule oral formulations.
  • Experience with pilot scale operations for solid dosage form manufacture is required.
  • Demonstrated understanding of GMP regulation and FDA/EMEA guidance on manufacturing process for small molecule and biologic products.
  • Proven track record of large scale process implementation is required.
  • Experience working with CMO’s preferred. 

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.

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