Sr. Analytical Scientist

Two95 InternationalDurham, NC
7d

About The Position

General Responsibilities: Plan and conduct analytical tests for drug development and transfer the methods to CDMO Analyze and interpret data and prepare technical reports Perform IQ/OQ/PQ and maintain lab equipment Follow safety procedures and good laboratory practice Must be able to work independently with limited guidance from external consultants or CEO (this role would report directly into the CEO). BS/MS with 10-12+ years of pharma industry analytical experience working within analytical development/validation to support solid oral dosage forms (small molecules), Ph.D. with 5-7+ years. Excellent method development and validation skills and routine analysis on pharmaceutical materials (including potent compounds). Strong preference for an analytical scientist who has used a variety of analytical techniques/instrumentation – for example, particle size analysis, TGA, DSC, HPLC, FTIR, Powder XRD, SEM, HPLC (Agilent), Dissolution, UV-Vis. Strong preference for an analytical scientist who either has worked within a contract analytical lab working with external clients or has worked within a pharma company who outsourced some analytical work to external CDMOs. Ability to self-manage and take on new tasks Ability to learn new analytical techniques by hands-on work and review of published data Ability to multi-task and hit project timelines. Excellent oral and written communication skills ANDA background a plus.

Requirements

  • BS/MS with 10-12+ years of pharma industry analytical experience working within analytical development/validation to support solid oral dosage forms (small molecules), Ph.D. with 5-7+ years.
  • Excellent method development and validation skills and routine analysis on pharmaceutical materials (including potent compounds).
  • Ability to self-manage and take on new tasks
  • Ability to learn new analytical techniques by hands-on work and review of published data
  • Ability to multi-task and hit project timelines.
  • Excellent oral and written communication skills

Nice To Haves

  • Strong preference for an analytical scientist who has used a variety of analytical techniques/instrumentation – for example, particle size analysis, TGA, DSC, HPLC, FTIR, Powder XRD, SEM, HPLC (Agilent), Dissolution, UV-Vis.
  • Strong preference for an analytical scientist who either has worked within a contract analytical lab working with external clients or has worked within a pharma company who outsourced some analytical work to external CDMOs.
  • ANDA background a plus.

Responsibilities

  • Plan and conduct analytical tests for drug development and transfer the methods to CDMO
  • Analyze and interpret data and prepare technical reports
  • Perform IQ/OQ/PQ and maintain lab equipment
  • Follow safety procedures and good laboratory practice
  • Work independently with limited guidance from external consultants or CEO
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