Experience with phase I, II, III and commercial stability, release, raw materials, method development, validations, compendial testing, and compendial verifications both in the lab as an analyst, supervisor, and manager. Experienced with raw materials, tablets, capsules, parenterals, liquid dosage, creams, gels, pastes, dermalogicals, and stints.Interact with Clients, Program Management, Directors, other Group Leaders, Team Leaders, Analysts and Support Staffs discussing project execution, timelines, progress, and working through any issues that arise.Equipment experience: HPLC, UPLC, GC(FID, HS, MS), ICP-MS, Dissolution (app 1,2, and 4), IC, laser deffraction particle size, Karl Fisher (volumetric and coulometric).Write and review protocols, reports, SOPs, testing procedures, and training programs.Set up current reference material program, which includes qualifications and characterization of material along with fractioning and shipping of material. Assisted LIMs team in creating the process of controlling reference material, managing control of material, and reporting results.Accustomed to working under ICH and VICH guidelines, cGMP, USP, EP, JP, BP for human and animal pharmaceuticals.
Listed skills include Hplc, Validation, Gmp, Gas Chromatography, and 43 others.