Careers

Title: Senior Scientist/Principal Scientist - Analytical Development

Location: Waltham, MA

Entasis is seeking a Senior Scientist or Principal Scientist in Analytical Development to join their team. In this newly formed role, you will be working with the Associate Director of Analytical Development on analytical development activities for CMC.

 

Responsibilities:

  • Support CMC Analytical activities for one or more development programs
  • Develop robust and appropriate analytical methods
  • Perform analytical testing as necessary
  • Oversee the validation of methods appropriate to phase of development
  • Trouble shooting analytical tests, methods and instruments
  • Oversee stability programs to support clinical development and regulatory filings
  • Oversee the reference standard programs
  • Transfer technology to external contract organizations
  • Work with contract organizations to ensure sound analytical data and results are reported
  • Summarize data and scientific findings in presentations and reports
  • Contribute to regulatory filings
  • Contribute to the development of product specifications
  • Demonstrate technical proficiency and problem solving in the field of Analytical Chemistry

 

Qualifications:

  • PhD in Analytical Chemistry with 8+years of related industrial experience or a Master’s degree with 15+ years of related industrial experience
  • Understanding of GxP operations
  • Understanding of ICH guidelines
  • Knowledge of compendial methods and standards
  • Knowledge of statistical analysis for the assessment of data
  • Demonstrated expertise with HPLC applications for small molecules
  • Drug substance and product method development, validation and transfer experience
  • Excellent analytical, written and verbal communication skills
  • Ability to work independently and in a team environment
  • Experience with MS, NMR and other spectroscopic techniques preferred
  • Proven analytical problem solving
  • Strong organizational skills
  • Ability to work across functional groups and with contract organizations

 

Apply Now