The R&D Scientist position is an individual contributor role. The job duties for this position include but are not limited to the following:
-- Operate as the subject matter expert (SME) on pre-formulation and formulation or process development or technology transfer or analytical sciences as applied to development, characterization, process analytical technologies (PAT) and incorporation of active pharmaceutical ingredients (APIs), excipients, packaging material and devices to develop finished products. Products may range from internal product development projects, products that are commercialized, products that are in-licensed from external entity or products that are co-developed with a development partner.
-- Conduct API, excipient, packaging or device characterization; excipient compatibility and forced degradation studies. Recommend stage appropriate acceptance criteria for vendor and regulatory specifications. Utilize relevant theoretical modeling and statistical tools, as required.
-- Develop robust lab-scale, pilot-scale and commercial-scale manufacturing process based on Quality by Design (QbD) principles using design of experiments (DOE). Recommend stage appropriate acceptance criteria. Utilize PAT where feasible. Utilize relevant statistical tools, as required.
-- Review and analyze relevant stability data from lab-scale, pilot-scale and commercial-scale, R&D and GMP stability studies by utilizing industry standard modeling and analysis tools including regression analysis for shelf-life prediction. Develop and implement strategies to control related substances, where applicable.
-- Operate as the subject matter expert (SME) on analytical methods. Techniques may include standard tools like HPLC, UPLC, UV, GC, LC-MS, Viscometer, Karl-Fisher, IR, Particle size analyses, XRPD, DVS, Rheometer etc. to more specialized techniques such as LS-MS/MS, NMR, SS-NMR, Synchrotron etc.
-- Doctorate in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.
-- In-depth understanding of physical pharmacy, physical chemistry, thermodynamics, chemical reaction kinetics is a must.
-- In-depth understanding of various pre- formulation and formulation studies including excipient compatibility, forced degradation studies and unit steps in formulation manufacture is a must.
-- Experience with pilot-scale and manufacturing-scale equipment is a plus.
-- Experience with process analytical technologies (PAT) is a plus.
-- In-depth understanding of UV-Vis, Liquid Chromatography (LC), Gas Chromatography (GC) and Spectroscopy techniques such that IR is a must. Experience with analytical techniques such as Dissolution, Particle Size Analysis, dynamic vapor sorption (DVS), x-ray powder diffraction (XRPD), mass spectrometry (MS), nuclear magnetic resonance (NMR) etc. is a plus.
-- In-depth understanding of theoretical principles of laboratory analytical techniques is a must.
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