AR&D Scientist I/II

Essential Functions

• Carr[ies out responsibilities in accordance with company policies, Standard Operating Procedures (SOPs) and state, federal and local laws
• Sets up and operates analytical instruments to support sample testing, including High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Violet Visible spectroscopy (UV/Vis), Infrared Spectroscopy (IR), Thin Layer Chromatography (TLC), automatic titration, Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Liquid Chromatography–Mass Spectroscopy (LC-MS) and dissolution apparatus
• Performs analytical method development and troubleshooting of existing analytical methods for in process (IP), finished products (FP) and stability (ST) sample testing
• Performs and guides laboratory analyses of raw materials, IP, FP and ST samples
• Designs and executes physical characterization studies to facilitate product understanding, such as rheological, microscopy, surface area and thermal studies
• Designs, guides and performs reverse engineering studies of Reference Listed Drug (RLD) to support Product development
• Designs, guides and performs pre-formulation studies (i.e, pH solubility, pH stability, excipients compatibility studies, etc.) in collaboration with PD
• Performs trend analysis of development stability results, investigates Out of Specification (OOS) and Out of Trend (OOT) results in support of project directives
• Provides analytical input to support complex technical investigations
• Documents all testing details and results in laboratory notebooks compliant with current Good Documentation Practices (cGDPs)
• Prepares analytical method development reports, technical protocols/reports and scientific packages for internal and external use
• Creates and reviews ARD SOPs, as needed
• Safely and properly disposed of chemical waste, as needed
• Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and current Good Manufacturing Practices (cGMPs)
• Cleans and organizes AR&D lab areas
• Performs related duties as assigned

Requirements

• Knowledge/Skills/Abilities Required
• Minimum education and years of relevant work experience for AR&D Scientist I: Bachelors degree in Chemistry or related science field and minimum 3 years experience in analytical/method development or method validation in the pharmaceutical or biotechnology industry OR Masters degree in Chemistry or related science field and minimum 0-3 years experience in analytical/method development or method validation in the pharmaceutical or biotechnology industry
• Minimum education and years of relevant work experience for AR&D Scientist II: Bachelors degree in Chemistry or related science field and minimum 4 years experience in analytical/method development or method validation in the pharmaceutical or biotechnology field OR Masters degree in Chemistry or related science field and minimum 2 years experience in analytical/method development or method validation in the pharmaceutical or biotechnology field OR PhD in Chemistry or related science field with 0-1 years experience in analytical/method development or method validation in the pharmaceutical, biotechnology and/or academic research field.
• Special knowledge or skills needed and/or licenses or certificates required: Carries out responsibilities in accordance with company policies, SOPs and state, federal and local laws
• Sets up and operates analytical instruments (i.e., High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Violet Visible spectroscopy (UV/Vis), Thin Layer Chromatography (TLC), automatic titration, dissolution apparatus, etc.) to support sample testing
• Performs laboratory analyses, such as blend uniformity, content uniformity, assay and dissolution, of IP, FP and ST samples per given instructions; Prepares standard and sample solutions as required by the test methods
• Performs wet chemistry tests such as Limit of Detection (LOD), pH and titration
• Performs physical tests such as particle size, viscosity and density measurements
• Performs all necessary calculations associated with test analyses
• Documents all testing details and results in laboratory notebooks compliant with current Good Documentation Practices (cGDPs)
• Creates ARD SOPs, as needed
• Safely and properly dispose of chemical waste, as needed
• Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and current Good Manufacturing Practices (cGMPs)
• Cleans and organizes ARD lab areas
• Performs related duties, as assigned