Staff Scientist, Analytical Development

Bayer•Morristown, NJ

9d•$145,000 - $170,000•Hybrid

About The Position

The Staff Scientist, Analytical Development will 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; and present findings regarding 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. The role requires a master's degree in Pharmaceutics, Pharmacy, Chemistry, or a closely related field and three years of specified experience. A bachelor's degree in one of those fields and five years of progressive post-bachelor's experience in the specified areas is also acceptable.

Requirements

Master's degree in Pharmaceutics, Pharmacy, Chemistry, or a closely related field, plus at least 3 years of relevant experience; alternatively, a bachelor's degree in one of those fields plus 5 years of progressive post-bachelor's experience.
Experience designing analytical experiments in the pharmaceutical and/or consumer products industry.
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.
Up to 10% U.S. and international travel is required.

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 their 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.