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Sr. Formulation Scientist

OVERALL RESPONSIBILITY:

Axcella is seeking a Senior Formulation Scientist with strong expertise in small molecules formulation to develop and optimize novel formulations for small molecules. Working in close collaboration with research and development teams to implement formulation requirements per CMC needs. The Formulation Scientist is expected to perform lab work as well as collaborate with external partners to drive and execute the development of successful oral formulations to support preclinical, clinical, and regulatory needs.

KEY TASKS AND RESPONSIBILITIES:

  • Design and execute pre-formulation and formulation experiments to enable oral administration of small molecules
  • Manage and monitor progress of formulation development and characterization work at contract research laboratories, including data review
  • Work in a team and contribute towards the development of novel formulations for small molecules
  • Implement formulation procedures at manufacturing scale in cGMP environment
  • Contribute to the writing of formulation sections for regulatory filings
  • Conduct all job responsibilities in a manner consistent with all applicable safety and environmental laws and regulations

SKILLS AND ATTRIBUTES:

  • Prior experience in development of oral formulations for small molecules is a requirement
  • Basic background in biology
  • Willing to develop expertise in statistics, statistical design of experiments, Process Analytical Technology and QbD experimentation
  • Ability to work in a highly collaborative and intellectually challenging environment, including excellent oral and written communication skills, to conduct both self-directed and guided computational research
  • Experience with protein drying techniques: lyophilization, spray drying, and others
  • Sufficient familiarity with regulatory requirements, GMP regulations, and compendial
  • Possess the ability to learn new processes, streamline processes and operational plans, act as “in-house” technical subject matter expert and apply broad technical knowledge to solve varying problems of high complexity

EDUCATION AND EXPERIENCE:

  • PhD level Scientist in pharmaceutical sciences or similar discipline with 5+ years relevant experience

If interested, we would welcome a cover letter and CV sent to careers@axcellahealth.com No phone calls please, and only those we will be following up with, will receive a reply.