Senior Scientist Formulation & Process Development – # 6345

Senior Scientist Formulation & Process Development – # 6345

The Senior Scientist of Formulation & Process Development will develop and optimize existing pharmaceutical products for the companion animal health market by applying formulations skills and knowledge. The incumbent will focus on development of formulation and process, with emphasis on reliability and consistency . The incumbent will provide technical expertise in collaboration with other functional groups to develop and optimize products, test new ingredients and issue material and product specifications. The incumbent will explore and develop novel dosage forms for the delivery of drugs to animals, prepare formulations development plans to help establish and meet project timelines, prepare laboratory-scale batches to evaluate initial stability for new formulations, perform pilot scale batches to test a variety of product dosage forms including tablets, liquids, powders, soft chews, sustained-release products and others. The incumbent will prepare product specifications in collaboration with the analytical and CMC teams. The incumbent will communicate all information regarding formulation, project status, results to all appropriate individuals, keeping in mind requirements for confidentiality.

The Senior Scientist will ensure products are developed in a timely fashion and in agreement with the development plan. The incumbent will handle process development, optimization and scale-up for new or optimized drug products. The incumbent will evaluate alternate API and excipient sources for use in manufactured products. The incumbent will troubleshoot problem processes and suggest improvements to manufacturing. The incumbent will perform pilot scale batches to meet registration and GMP requirements. The incumbent will create manufacturing protocols and summary reports for development engineering, clinical and registration batches. The incumbent will assemble documentation necessary for FDA submissions and will ensure the process is mastered toward and accurate, robust and repeatable process.

Qualifications include a BS Chemistry, Pharmaceutical Science, Chemical Process Engineer or advanced degree. 6-10 years of experience in the pharmaceutical-related field. A high level of Mastery of skills in formulation science and process development in a GMP environment is preferred.

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