Description
We are seeking a Staff Scientist, Analytical Development to join our team in Morristown, NJ. As a Staff Scientist, you will design analytical experiments for method development, method validation, and method transfer to manufacturing sites. You will perform laboratory work, prepare product specifications, plan stability studies, and interpret results. Additionally, you will present findings regarding the underlying chemistry of products in the pipeline.
Responsibilities:
- Design analytical experiments for method development, method validation, and method transfer to manufacturing sites
- Perform laboratory work using techniques such as HPLC, LC-MS, GC, UV-Vis, FT-IR, and AAS
- Prepare product specifications and plan stability studies
- Interpret results and 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-IR letters
- Perform Accelerated Stability Assessment Program stability studies on drug products
- Draft and close OOT and OOS investigations, CAPA's, and lab-related deviations using Veeva
Requirements:
- Master's in Pharmaceutics, Pharmacy, Chemistry, or a closely-related field
- 3 years of 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
- Experience managing CMOs and CDMOs
Telecommuting is permitted from a home office location within a reasonable commuting distance of Morristown, NJ, up to 1 day per week. Up to 10% U.S. and international travel is required.
Salary Range: $145,000.00 to $170,000.00 per year. Additional compensation may include a bonus or commission. Benefits include health care, vision, dental, retirement, PTO, sick leave, etc.