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Senior Formulation Scientist
ce knowledge of theories, practices and principles of Physical pharmacy, pharmaceutics, pharmacokinetic, bio-pharmaceutics and statistical designs is required. The candidate should be well conversant to product design of controlled release dosage forms with hands on knowledge of multi-particulate systems, diffusion controlled, osmotically controlled and hot-melt granulation controlled systems. The candidate has to Identify and evaluate the critical formulation factors (e.g., components and process) and coordinate development with AR&D, Engineering, Validation, Production, Regulatory, and QC, to ensure uninterrupted progress. The candidate should be well versed with documentation practices associated with product development and is responsible to prepare CMC section including but not limited to Pharmaceutical Development Report and QOS. The candidate is also expected to prepare process evaluation, scale-up, pre-validation & qualification protocols, execute batches as per the protocols, analyze data, and prepare summary reports. Understand material characteristic and product quality attributes thoroughly and identify the most suitable processes to manufacture the product meeting all intended quality attributes. Qualifications: Ph.D. in pharmaceutical sciences or pharmaceutics with a minimum of 4 years, M.S. in pharmaceutical sciences or pharmaceutics with 6+ years. Ability to efficiently handle pharmaceutical unit operations, such as fluid bed coater, bilayer compression, roller compaction, high shear granulation, particle/ pellet coating (wuster process) and tablet coating ( IR, DR and drug loading) and encapsulation. Performing statistical analyses including design of experiments. Coordinating and reviewing the assigned work, establishing and maintaining cooperative working relationship with others. Experience in handling Controlled substances is added advantage. Ability to troubleshoot, solve and/or elevate technical problems with formulations and existing products
Farmington, New Mexico
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