Director, Analytical Development – Oligonucleotides

1 month ago

Boston, United States Kennedy Bond Full time

We are looking for an established Analytical Scientist to join the CMC Leadership team and head the entire Analytical function of an up-and-coming Biotech, focused on neurological diseases. Backed by a well-known Venture Capitalist firm, our client, who’s operating in stealth mode, will be entering in the clinic in the next 5-8 months. This role, reporting to the Chief Technical Officer, will be a hands-on leadership position, providing scientific direction in the lab, continue Analytical efforts for their lead program, and establish phase appropriate methods as the program progresses. In addition, this position will be responsible for..


Main responsibilities:

  • Leading development of structural assays for Oligonucleotides
  • Focusing on method development for various biophysical and biochemical assays to develop their capabilities
  • Ensure QC release and stability testing to meet product requirements.
  • Lead a team of 5 direct reports
  • Interact with Regulatory agencies, provide scientific and leadership guidance to junior personal, collaborate effectively with cross functional teams
  • Define strategy for Analytical development for assays to support Process and Platform Development
  • Write validation reports and necessary documentation for regulatory submissions


Experience:

  • PhD with 5-10 years of industry experience, particularly in Analytical/ Method Development (in a CMC capacity, opposed to Preclinical)
  • Ideally, modality experience overseeing Oligonucleotides
  • SME of physical properties of API’s themselves
  • Experience with Flow Cytometry and Characterization
  • Evidence of people management or leading matrix groups,
  • Validation and method development of structural assays is a must
  • Antibody development and screening, Western Blot, and Elisa

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