Lead development of formulations and processes for both immediate- and modified-release generic solid oral and alternative dosage products.
Essential Duties and Responsibilities:
Develop controlled release and immediate release solid oral dosage forms. This includes performing literature search, pre-formulation investigations, formulation design, prototype formulation manufacturing in R&D environments, process scale-up and optimization at manufacturing facilities, and exhibit batch and clinical supplies manufacturing.
Perform all project related scientific/technical activities such as interpretation of regulations and patents, design of experiments, troubleshooting formulation and processing problems, evaluation of physical and analytical data, and careful documentation of all work. The above activities may be performed independently or under the guidance of management.
Regularly update management on project activities and results through informal conversations and formal presentations.
Prepare regulatory submission documents including the Product Development Report and other relevant sections of the CMC portion of the filing.
Organize and manage the logistics of formulation development to ensure timely completion of all formulation development tasks.
Diligently perform DEA tracking of controlled API during formulation and scale-up activities.
Observe all safety and GMP guidance and adhere to internal SOPs.
Work in cross-functional teams that include Analytical R&D, Pharmaceutical Technology Transfer, Manufacturing, Quality Control, and Quality Assurance during the product development cycle.
Candidate must have a BS / MS or a Ph.D. degree in Pharmaceutical Sciences, Chemical Engineering or related field with 3-6 years of relevant experience in oral solids product development in pharmaceutical industry. Generics R&D experience and successful track record of ANDA submissions is a desirable. Experience with modified release dosage forms is a plus. The candidate must be self motivated and be able to execute independently. Good problem solving and project management skills are critical for this position. The candidate must have excellent written, verbal communication and interpersonal skills.
Travel Requirement :
20% May require travel to manufacturing site both internal and external
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