Product Development Scientist: Require Master’s degree in chemistry, biochemistry, pharmacy or related field. Perform product development. Optimize extraction procedures for plant extracts at different temps & diff. drying methodologies. Perform extractions of plant materials using different solvent systems. Perform stability studies of plant extracts. Formulate development of plant extracts into tablets, capsules, liquids, etc. Review & approval of formulation batch records for clinical batch manufacturing. Qualify, prepare, review & document clinical batches of the products for clinical studies. Prepare SOPs for manufacturing ops, packaging, receiving, QC, shipping, training of personnel, etc. Procure & maintain GMP conditions in the facility. Coordinate QC testing. Review final certificates of analysis to ensure specifications are met. Maintain proper QC test result documentation. Assist with QA audits. Knowledge in solid dose product development & manufacturing scale up, powder granulations, tablet press, encapsulation machines, ribbon blenders, V-blenders, fluid-bed drier, pan coaters, Thin Layer Chromatography, UV-Vis Spectrophotometer, Disintegration & Dissolution apparatus, plants biochemistry, solvents & extraction conditions including temperature & pressure on the bioactive components of plants, stability kinetics, freeze drying & spray drying techniques, quality control methodologies, lubricants, lubricant additives, tribology, natural active molecules, analytical method validation, process validation/transfer protocols, analytical instrument/equipment qualification reports, data analysis, high performance liquid chromatography. Conversant with GMP regulations for clinical batch manufacturing, GMP documentation for manufacturing, labeling, testing, storage & distribution of drug products for commercial distribution, SOPs based on global quality standards, good documentation practice procedures, & CAPA Plan. Proof of knowledge required.
40hrs/wk. Work location: New Brunswick, NJ.
Send Resume: Natreon, Inc., 2D Janine Pl, New Brunswick, NJ 08901.
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