R&D Formulation Sr Scientist I

Nature and Scope Responsible for formulation and process development activities associated with parenteral drug product development following Quality by Design (QbD) principal. Participates in manufacturing process scale-up and technology transfer. Supports trouble shooting of manufacturing issues, ANDA submission and regulatory response to FDA deficiency. Responsible for training of laboratory personnel in areas of expertise. Essential Duties and Responsibilities Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time. Conduct literature search and pre-formulation studies on new generic products. Design and execute parenteral formulation studies in accordance with company procedures and appropriate FDA/ICH guida