Senior Scientific Manager - Formulations R&D

Role Overview: As a Formulations Scientist in Hyderabad, India, you will be responsible for the development of oral solid dosage forms of Non-DEA and DEA substances. Your key functions will include conducting Literature Search, Pre-Formulation, Formulation Design, and Development of stable, Bioequivalent, and Manufacturable generic solid oral formulations. Key Responsibilities: - Act as a mentor and motivator to the team. - Develop robust formulations and processes for immediate release and modified release tablet and capsule dosage forms. - Evaluate patents and develop non-infringement strategies, including the capability of developing Paragraph IV products. - Scale-up and optimize manufacturing processes, execute pre-exhibit and exhibit batches, and facilitate technology transfer from R&D to production to meet timelines. - Plan and contribute to project-related scientific/technical activities such as interpreting results, critically assessing data, drawing relevant conclusions, and writing reports. - Author technical documents including Product Development Report, Quality Overall Summary, and other relevant documents for regulatory filing purposes. - Interact with API manufacturers, CROs, and CMOs as necessary. - Proactively work with cross-functional groups to execute change controls associated with Manufacturing and Packaging master records, SOPs, and protocols. - Create and review SOPs, review documentation and test results for accuracy, completeness, and compliance with SOPs/GMP requirements. - Coordinate with Regulatory Affairs for filing ANDAs and addressing deficiencies, providing relevant documents for ANDA filings and Supplements filing. - Review batch records, process characterization reports, validation reports, and investigation reports. Qualification Required: - Masters with a minimum of 13 years or a Ph.D. degree in Pharmacy with at least 5 years of relevant experience in oral solids product development in the generic pharmaceutical industry. - Must have Generic R&D experience and a successful track record of AND submissions. - Experience with modified release dosage forms is a plus. - Self-motivated with excellent written and verbal communication skills. - Possess good interpersonal and project management skills. (Note: Additional details about the company were not provided in the job description.),