Staff Scientist, Analytical Development

Bayer•Morristown, NJ

8d•Hybrid

About The Position

The Staff Scientist, Analytical Development will design analytical experiments for method development, method validation, and method transfer to manufacturing sites. The role involves laboratory work, preparing product specifications, planning stability studies and interpreting their results, and presenting findings about the underlying chemistry of products in the pipeline. The position is based in Morristown, New Jersey. Telecommuting from a home office within reasonable commuting distance of Morristown is permitted up to one day per week. Up to 10% domestic and international travel is required.

Requirements

Master’s degree in Pharmaceutics, Pharmacy, Chemistry, or a closely related field and 3 years of experience designing analytical experiments in the pharmaceutical and/or consumer products industry; alternatively, a Bachelor’s degree in one of these fields and 5 years of progressive post-Bachelor’s experience in the stated areas.
Experience applying HPLC, LC-MS, GC, UV-Vis, FT-IR, and/or AAS to validation and/or stability studies for pharmaceuticals.
Experience performing method development and validation of pharmaceutical tests, including assay, impurities, and dissolution.
Experience evaluating and interpreting stability data.
Experience performing in-vitro release testing of topical and/or transdermal dosage forms.
Experience managing CMOs and CDMOs for analytical development, validation, and stability studies for drug substances and/or drug products.
Experience drafting responses to deficiencies from EMA, ROW, and/or FDA information request letters.
Experience performing Accelerated Stability Assessment Program stability studies on drug products.
Experience drafting and closing OOT and OOS investigations, CAPAs, and laboratory-related deviations using Veeva.
Able to travel up to 10% in the U.S. and internationally.

Responsibilities

Design analytical experiments for method development, method validation, and method transfer to manufacturing sites.
Perform laboratory work.
Prepare product specifications.
Plan stability studies and interpret results.
Present findings regarding the underlying chemistry of products in the pipeline.
Manage CMOs and CDMOs to deliver comprehensive and compliant analytical development, validation, and stability studies for drug substances and/or drug products.
Draft responses to deficiencies from EMA, ROW, and/or FDA information request letters.
Perform Accelerated Stability Assessment Program stability studies on drug products.
Draft and close OOT and OOS investigations, CAPAs, and laboratory-related deviations using Veeva.