Ocean City Metro Area, NJ
implementation of analytical methods involving modern analytical instrumentation including HPLC/UPLC,
GC, dissolution, FT-IR, Karl Fischer titrations, etc.
Transfers validated methods to customer labs, including partner-owned quality control (QC)
Performs testing for development and clinical materials and stability samples in accordance with established
methods, specifications and protocols under supervision.
Knows the fundamentals of analytical methodology and can troubleshoot instrumentation and method
performance issues of routine complexity.
Documents / reviews laboratory work using laboratory notebooks / worksheets that is detailed, timely and in
compliance with GLP / GMP requirements.
BS/MS Chemistry (or relevant discipline).
Minimum 3 years cGMP / GLP pharmaceutical laboratory experience
Hands-on experience with separations techniques (HPLC, UPLC, GC, etc.)
Familiar with HPLC, dissolution, FT-IR, UV/VIS spectrophotometry, titrations, etc.
Experience in laboratory investigation and documentation of Out-of-Specification results.
Experience in the development and performance of analytical tests for a variety of drug substances and
products (including solid oral dosage forms and injectables) is a plus.