Job Title: Associate Scientist, Stability Department: Stability Position Summary We are seeking a detail-oriented and proactive Associate Scientist to join our cGMP API Stability Laboratory. This role involves supporting analytical stability studies in compliance with regulatory guidelines. The ideal candidate will have hands-on experience with small molecule drug substances and drug product batch release and stability testing, and experience working in a cGMP environment. Essential Responsibilities + Conduct stability testing (e.g., HPLC, KF, XRD, DSC, TGA) and support activities in a cGMP-regulated laboratory. + Coordinate the timely and compliant generation of stability data to support client projects. + Author and review stability protocols and reports. + Perform out of specification (OOS) investigations, identify potential root causes, and support implementation of corrective actions. + Review laboratory data for technical accuracy and regulatory compliance. + Manage laboratory inventory, environmental chambers, and related information systems. + Collaborate with clients to design appropriate batch release and stability studies for APIs and drug products. + Develop and maintain expertise with applicable ICH, FDA, and EMEA stability guidelines. Qualifications Education and Experience: + Bachelor’s degree in chemistry or a related scientific discipline required. + Minimum of 2 + years of relevant analytical laboratory experience in a cGMP environment, or an equivalent combination of education and experience. + Relevant experience in a quality control or stability laboratory is essential. Skills and Competencies + Hands-on experience with standard laboratory instruments (e.g., HPLC, analytical balances, pH meters, titrators,etc.) + Familiarity with ICH stability guidelines preferred. + Experience working in a GMP compliant laboratory setting is preferred. + Proficient in laboratory techniques such as assay, impurities testing, sample preparations, dilution, etc. + Strong skills in Microsoft Word and Excel + Experience with OOS investigations and root cause analysis is preferred. + Solid understanding of arithmetic, algebra, and basic statistical concepts. + Strong communication skills with the ability to interact effectively with clients and internal teams. + Ability to manage multiple tasks and prioritize effectively in a fast-paced environment.