Scientist/Analytical Chemistry

Sci.bio Recruiting

Looking for an experienced analytical chemist to work remotely for Boston area company.

Job Summary:
Assist with providing high quality analytical method development and validation in a GMP environment. The qualified candidate will take an active role in supporting drug development by applying a variety of analytical methodologies to support physical and chemical characterization of drug products.  This candidates will be highly engaged with method development transfer to CMO's and CRO's.
 
Essential Responsibilities:
  • Participate in the development and validation of analytical methods and improvement of existing ones to support all stages of drug development from drug substance characterization through formulations and process development and regulatory submissions.
  • Analytical method development and validation; stability and release testing; testing to support pharmaceutical development efforts
  • Direct interaction with project team members, including presentation of data; critical review of data; preparation of technical reports; and evaluation of new instrumentation or analytical techniques.
  • Assist in the evaluation and interpretation experimental data.  
  • Prepare and review analytical data, technical reports and analytical methods in support of and for inclusion in the regulatory submissions.
  • Compile, maintain, review and interpret analytical and statistical data. Assist with generating high quality technical documents required for method validation and NDA submissions. 
  • Maintain and follow all laboratory systems, GMP regulations.
  • Vendor Management of CMO's
  • Prepare and review SOPs, as required.
  • Assume other activities and responsibilities as directed.
Qualifications for Analytical Scientist:
  • M.S. or Ph.D. in Pharmaceutical Chemistry, Analytical Chemistry, Chemistry, or Pharmaceutical Sciences with relevant working experience in pharmaceutical industry.
  • Working knowledge in analytical method development and validation under cGMP environment.
  • Good oral and written communication skills and the ability to write and review technical reports and scientific papers are desired.