Scientist II/Sr. Scientist, Analytical Development

Technical Operations Lexington, Massachusetts


Description

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Scientist II/Senior Scientist, Analytical Development 

Kaleido Biosciences is a clinical-stage biotechnology company engaged in the development of novel chemistries that unlock the power of the microbiome to revolutionize health. The Company has built the first R&D engine to systematically create, discover, and develop interventions that activate metabolic processes in the microbiome to treat disease and maintain health. Since its founding in 2015 by Flagship Venture Labs, Kaleido has advanced candidate products into clinical studies across programs for rare genetic diseases, oncology and infectious disease. The Company is also creating consumer products that optimize the microbiome's natural roles in promoting health.

Overview:

We are looking for an experienced analytical chemist to join our companyReporting to Sr. Director of Analytical Development, this person will work as an internal expert on method development and as an SME on method validation and method transfer to external CROs and CMOs. The role will be key for developing release methods, characterizing our complicated oligosaccharides, and using research results to influence scientific and strategic direction of development projects. 

 

This position requires strong collaborative skills, multi-tasking ability, and desire to drive the projects with scientific justifications. Previous experience with method development, method transfer and validation in cGMP-compliant environment are highly desired. 

 

Summary of Key Responsibilities:

  • Develop and optimize robust analytical methods for batch release and characterization.
  • Analyze samples, review data, and generate CoAs for reference standards and R&D batches, to support the internal and external development projects.
  • Author, review and manage technical protocols, reports, SOPs, and maintain clear laboratory notebooks.
  • Tutor junior scientists in daily operation.
  • Work closely with external CROs and CMOs in method development/transfer/validation, reference standard qualification and stability programs.
  • Review/draft analytical sections for regulatory submissions in collaboration with other teams.
  • Maintain and troubleshoot analytical laboratory instruments.

 

Qualifications:

  • M.S. with 5+ years working experience or Ph.D. with 2+ years working experience in pharmaceutical/biotech industry.
  • Knowledge of multiple types of analytical and chromatographic separation techniques, such as HPLC, GC, and MS.
  • Previous experience on releasing and characterization method development. Working experience in cGMP-compliant environment or in the fields of oligosaccharides or polymeric compounds is strongly preferred.
  • Ability to follow cGMP requirements, keep detailed records, and competently peer-review analytical data and results.
  • Competency with common laboratory operations.
  • Good interpersonal skills and ability to work well in a team.
  • Experience with ChemStation or Empower.

 

Kaleido Biosciences is an EEO employer committed to an exciting, diverse, and enriching work environment