Staff Scientist, Analytical Development

Summary

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 underlying chemistry of products in pipeline.

Job description

Requirements

• Master's degree in Pharmaceutics, Pharmacy, Chemistry or closely-related field with 3 years experience designing analytical experiments in pharmaceutical and/or consumer products industry
• Or Bachelor's degree in above-stated fields with 5 years progressive post-Bachelor's experience
• Applying HPLC, LC-MS, GC, UV-Vis, FT-IR and/or AAS to validation and/or stability studies for pharmaceuticals
• Performing method development and validation of pharmaceutical tests including assay, impurities, and dissolution
• Evaluating and interpreting stability data
• Performing in-vitro release testing of topical and/or transdermal dosage forms
• Managing CMOs and CDMOs for analytical development, validation, and stability studies for drug substances and/or drug products
• Drafting responses to deficiencies from EMA, ROW, and/or FDA-IR letters
• Performing Accelerated Stability Assessment Program stability studies on drug products
• Drafting and closing OOT and OOS investigations, CAPAs, and lab-related deviations using Veeva
• Up to 10% U.S. and international travel required

Benefits

• Health care
• Vision
• Dental
• Retirement
• PTO
• Sick leave

Company overview

Bayer AG is a global life science company with core competencies in healthcare and agriculture, operating as one of the world's leading pharmaceutical corporations. Founded in 1863 and headquartered in Leverkusen, Germany, Bayer operates through three primary divisions: Pharmaceuticals, Consumer Health, and Crop Science. The company's pharmaceutical segment focuses on prescription products for cardiology, women's healthcare, oncology, hematology, and ophthalmology, with blockbuster drugs including Xarelto, Eylea, and Nubeqa. Bayer's Consumer Health division markets well-known over-the-counter brands such as Aspirin, Aleve, Claritin, and Bepanthen. The Crop Science division, strengthened by the acquisition of Monsanto, provides seeds, crop protection products, and digital farming solutions. With approximately 92,815 employees worldwide and operations in 80 countries, Bayer is committed to its mission of "Health for all, Hunger for none," driving innovation in medical treatments, agricultural productivity, and sustainable development. The company maintains a strong research and development pipeline, investing heavily in areas like precision medicine, artificial intelligence applications in healthcare, and sustainable agricultural technologies.