Senior Director/Director - Head of Analytical Development

Cambridge, Massachusetts, United States Full-time

Sr. Director/Director, Head of Analytical Development

This is an outstanding leadership opportunity to join a fast-paced company in a new exciting field of medicine.  Evelo Biosciences is dedicated to improving the lives of patients globally through the development of monoclonal microbials.  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 Head of Analytical Development who is interested in joining a highly dynamic and intellectually challenging team. This leadership role will afford a qualified candidate an opportunity to work in an innovative, fast paced environment and shape Evelo’s vision to bring new products to patients.  Reporting into the SVP, Head of Process Development and Manufacturing, the successful candidate will be responsible for establishing and leading Evelo’s drug product development strategy.

 

Primary Responsibilities:          

  • Define and execute overall strategies for analytical development within Evelo
  • Lead and oversee all facets of analytical development including structure elucidation, method development and validation, stability studies, method transfer, testing of clinical materials and reference standards internally and through the management of CMOs and CROs
  • Provide support for method transfer and GMP clinical manufacturing
  • Responsible for authoring CMC related sections for regulatory filings and development reports
  • Deliver technological innovation in novel analytical techniques for product characterization
  • Lead and oversee Evelo technical team members
  • Partners with CMC development team

Desired Skills & Qualifications:

  • A self-starter and strategic thinker with a demonstrated ability to drive for results and lead innovation.
  • Proven ability to drive technical strategy as well as lead and influence cross-functional teams.
  • Successful in developing and broadly communicating cross-functional technical strategy and direction in support of CMC deliverables
  • Outstanding track record of collaboration, stakeholder relationship management, and influencing key decision makers.
  • Demonstrated understanding of industry trends, practices, techniques, and standards which impact the business and can translate that knowledge into action plans.
  • Strong analytical skills and ability to distill key information from various data sources.
  • Demonstrated technical project management and/or project leadership experienc
  • Proven ability to operate with a high level of ambiguity while making sound and timely decisions based on project priorities and risk assessments.
  • Demonstrated experience in leading and mentoring talent.
  • Excellent communication skills – written and verbal.
  • Ability to travel up to 30%

 

Education & Experience:

  • The successful candidate will have a MS/Ph. D in Biotechnology, Immunology, Molecular Biology, Biochemistry, or related field.
  • Minimum of 10 years of experience in analytical method development. Previous experience with biologics or live bacteria products is a plus.
  • Broad understanding of analytical sciences and regulatory/GMP requirements, and a proven track record in analytical development for clinical stage programs. Experiences in supporting commercial manufacturing is a plus.
  • Recognized as an expert in analytical development. Experiences in bioassay is a plus.
  • Significant technical project management and/or project leadership experience

 

About Evelo

Evelo Biosciences is dedicated to improving the lives of patients globally through the development of a new modality of medicines – monoclonal microbials. Monoclonal microbials are orally delivered medicines that modulate systemic immunology and biology through direct interactions with human cells in the gut. These new medicines are broadly applicable across many diseases – including autoimmune, immunoinflammatory, metabolic, neurological, neuroinflammatory diseases and cancer. Monoclonal microbials have the potential to fundamentally change traditional models of drug discovery and development. By finding and selecting naturally occurring monoclonal microbials with defined therapeutic effects, Evelo can improve the speed, cost and success of drug discovery and development. Evelo’s platform enables pharmacological intervention at all stages of disease with naturally occurring, safe and effective monoclonal microbials. Evelo Biosciences was conceived and created within VentureLabs®, Flagship Pioneering’s institutional innovation foundry, and launched by Flagship in 2015. For more information, please visit www.evelobio.com.

 

Apply for this opening at http://evelobio.recruiterbox.com/jobs/fk0fa3t?apply=true