Sr Research Scientist-Formulations

Company: System One
Location: East Brunswick
Posted on: January 22, 2023

Job Description:

Title: Sr. Research Scientist- Formulations Location: East Brunswick, NJ area Type: Direct Hire Start Date: ASAP Responsibilities:The R&D Sr. Scientist role is responsible for performing formulation and process development studies, generating documents, and scale up processes in support of ANDA or NDA filings. Work across the development/scale up/technical transfer projects. Work with subject matter experts, operation, and quality. Responsible for development/validation/investigation report with appropriate justifications, conclusion, and recommendations.Plan, perform and direct development activities for new products. Drive and monitor operational performance.Coordinate development activities for each drug product with the respective departments.Provide technical expertise and guidance for troubleshooting & problem-solving activities related to process and product investigations.Perform activities related to the formulation and process scale-up activities. Identify & select the appropriate ingredient required for use in new product development and perform scientific review for specification of raw materials and coordinate with suppliers as appropriate.Oversee manufacture of products using production equipment, such as batches for ANDA submissions, bioequivalence studies, and/or process scale-up.Provide technical support of ongoing manufacturing for new and currently produced products at the site.Work proactively with QA, Manufacturing, and other groups and coordinate/manage manufacture of registration/bio, validation, and initial commercial batches.Review and prepare master manufacturing batch records and process characterization protocols/ cleaning protocol using MACO calculation.Develop components of the product development report, process development report, and process parameter justification reports.Use advanced mathematical tools to develop in accordance with acceptable QbD.Maintain knowledge pertaining to cGMP documents and guidance, other regulatory guidance and GMP SOPs and comply with company standard operating procedures and currently accepted practices to assure product quality, safety, and efficacy.Support preparation of CMC documentation for the FDA and other international regulatory submissions. Assist in getting ready for pre-approval inspection (PAI). Requirements: B.S. in Pharmaceutical Science or related discipline plus a minimum of 6 years' experience.M.S. in Pharmaceutical Science with 4 years of experience.Ph.D. in Pharmaceutical Science with 2 years of experience.Background in formulations Indirect supervision, mentoring, and negotiating skills.Experience having developed and filled ANDA and NDAKnowledge of Technical techniques to evaluate formulations, immediate and modified release dosage forms, technology transfer methodologies, or advanced unit operations.Knowledge of the overall drug development and commercialization process from development, launch and through life cycle managementWorking Excellent managerial skills; including project management, problem-solving, written and verbal communications, and organizational abilities.Hands-on formulation research and development as well as formulation scale-up experience is desired, knowledge of US FDA registration guidelines.Good team player and self-starter, innovative and comfortable in a multi-disciplinary team under defined timelines.

Keywords: System One, East Brunswick , Sr Research Scientist-Formulations, Other , East Brunswick, New Jersey