Master’s degree or foreign equivalent in Chemistry, Pharmaceutical Manufacturing or related field plus 2 years of experience with the following: Developing stability indicating methods with OpenLab CDS, GPC for Assay, Purity, Residual Solvents, cleanout, Particle size using HPLC (UV-Vis, CAD, RID, GPC), GC (direct injection & HS), TOC, UV-Vis, PSD, Auto-titration for API (DS)Final release, stability study of API, in-process, raw materials, Cleanout samples and non-API products, in a fast-paced, CMO, cross functional, multi task environment, all under cGMP and ICH guidelines. Writing, executing protocols and validation analytical methods using mainly OpenLab CDS, and GPC software to prove methods are suitable for intended use based on ICH and USP/EP requirements to support API lifecycle from early development to clinical stages and registration in a fast-paced, CMO, cross functional, multi task environment, under cGMP and ICH guidelines. Effective coordination with customer for development, manufacture, release of product for new drug evaluations (NDEs) by supporting analytical aspects of project to meet project timelines. Working with stakeholders (Regulatory Affairs, EH&S, process chemists, process engineers) to optimize methods and process and to establish appropriate specification for raw material in-process and final release testing. Writing lab SOPs, CCR, CAPA, QI, LIR, OOS, OOT, NL.
Please send resumes to Lauren Martin PCI Synthesis 9 Opportunity Way Newburyport, MA 01950