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Senior Scientist, Analytical Research & Development
Columbus, OH
Overview
Conducts analytical activities in support of the development of a manufacturable multisource pharmaceutical product.
Responsibilities
Conducts testing, analytical method development and validation in support of regulatory submissions and product launch activities. Participates in method transfer activities. Applies scientific principles and technologies. Analyzes and interprets experimental data from laboratory work. Identifies, offers, and implements contingency plans to prevent and overcome analytical issues and perform method trouble shooting. Supports and suggests process improvements/changes to refine current systems and improve efficiency. Reviews and checks analytical data generated by peers and maintains integrity of data. Supports activities to maintain laboratory compliance to FDA/regulatory standards. Interfaces with enabling service teams such as Laboratory Services, Document Control, Logistics and Environmental Health and Safety regarding support needs and compliance. Ensures that all technical and safety training is current. Understands appropriate regulations and legal requirements as well as company policies and procedures relevant to areas of expertise. Ability to operate and troubleshoot the following instrumentation/techniques: High Performance Liquid Chromatography, Ultra Performance Liquid Chromatography, Gas Chromatography, Inductively Coupled Plasma-Mass Spectrometry (ICP-MS), Inductively Coupled Plasma-Optical Emission Spectroscopy (ICP-OES), Liquid Chromatography-Mass Spectrometry (LC-MS), Dissolution, Karl Fisher Titration (water content analysis), Fourier-Transform Infrared spectroscopy, Malvern particle size analyzer. Perform Droplet Size Distribution (DSD) Spray Content Uniformity (SCU), Spray Pattern and Plume Geometry associated with nasal spray and inhalation testing. Test Active Pharmaceutical Ingredients (APIs) and associated characterization techniques like Differential Scanning Calorimetry (DSC), Dynamic Vapor Sorption (DVS) and Thermal Gravimetric Analysis (TGA).
Qualifications
Must have a bachelor’s degree in chemistry, pharmaceutical sciences, a related scientific discipline, or equivalent and five years of progressive post baccalaureate pharmaceutical experience 1) in development and validation of wet analytical methods for drug substances and drug products, 2) using analytical instrumentation including HPLC (UV, RI and MS detection), GC, and ICP-MS, 3) in analyzing APIs with techniques like wet particle size distribution analysis using a Malvern particle size analyzer, and 4) with relevant FDA guidance documents. Alternatively, must have a master’s degree in chemistry, pharmaceutical sciences, a related scientific discipline, or equivalent and three years of pharmaceutical experience 1) in development and validation of wet analytical methods for drug substances and drug products, 2) using analytical instrumentation including HPLC (UV, RI and MS detection), GC, and ICP-MS, 3) in analyzing APIs with techniques like wet particle size distribution analysis using a Malvern particle size analyzer, and 4) with relevant FDA guidance documents.
Those interested in this position, please contact M. Benemar at mbenemar@hikma.com (Requisition #7529).
