Stability Scientist

Job Summary

Responsible for overseeing the stability product strategy, the full-time Scientist Stability will manage stability programs for large molecule Drug Substances and Drug Products, author stability protocols, and prepare regulatory filings while working onsite in New Brunswick, NJ.

Key Responsibilities

• Act as Stability Product Lead for assigned brands, participating in transfer teams and conducting gap analyses for new products
• Develop and maintain expertise in the stability performance of products, ensuring compliance with global supply chain standards
• Author stability sections of regulatory documents and serve as the stability representative for investigations related to quality issues

Required Qualifications

• B.S. in Chemistry, Biology, Microbiology, or a relevant discipline
• Five years of relevant work experience in a pharmaceutical environment
• In-depth knowledge of ICH Guidelines and cGMP regulations as they apply to stability programs
• Experience with stability data evaluation and statistical software
• Proficiency in Microsoft Office applications and Laboratory Information Management Systems (LIMS)