Andrew Bach

Background

About Andrew Bach

Master of Science in chemistry with an excellent knowledge of the CMC drug development process, strong leadership, communication and inter-personal skills, solid knowledge of chemistry-related fields, several years of process and analytical R&D laboratory experience and a solid reputation as a detail-oriented, results-driven, self-motivated worker that adheres to all company standards for quality, safety, and ethics. Can be counted upon to produce high-quality deliverables that meet all requirements, even under accelerated timelines.Possesses extensive experience in the areas of analytical and organic chemistry, project management and quality assurance (QA), and proficient in the generation, review and approval of documentation (e.g, SOPs, control procedures, specifications, validation protocols and reports, stability reports, instrument qualifications) for the GMP release of molecular entities (e.g, raw materials, intermediates, and drug substances) and for inclusion in health authority submissions (e.g, INDs, IMPDs, NDAs, CTDs). Well-trained in root cause analysis and in the processes used to conduct and document quality events (e.g, LIRs, DEVs, CAPAs, change controls).Participant in several global projects (e.g, drug development including submissions) and networks (e.g, GMP, GTI (genotoxic impurity)) and familiar and comfortable working with associates with diverse backgrounds from several international sites (e.g, Europe, South America, Asia) and from different functional areas (e.g, Research, Chemical Development, Tox, QA, Reg-CMC, DRA, TechOps). Strong expertise in the use and the following GMP documentation and data acquisition systems:Documentum (as Document Administrator)Trackwise (as Analytical Expert),LIMS (as Analytical Expert),Chromeleon (as Analytical Expert), eSOPs (as Author/Reviewer) Well-versed in the use of standard PC applications (e.g, Microsoft Office, Outlook, Adobe Acrobat).