Senior Scientific Manager - Formulations R&D

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. Your responsibilities will include: - Being a good mentor and motivator to the team. - Developing robust formulations and processes for immediate release and modified release tablet and capsule dosage forms. - Evaluating patents and developing non-infringement strategies, including the capability of developing Paragraph IV products. - Scaling up and optimizing the manufacturing process, executing pre-exhibit and exhibit batches, and ensuring technology transfer from R&D to production to meet timelines. - Planning and contributing to project-related scientific/technical activities, such as interpreting results, critically assessing data, drawing relevant conclusions, and writing reports. - Authoring technical documents like Product Development Report, Quality Overall Summary, and other relevant documents for regulatory filing purposes. - Interacting with API manufacturers, CROs, and CMOs as necessary. - Working proactively with cross-functional groups to execute change controls associated with Manufacturing and Packaging master records, SOPs, and protocols. - Creating and reviewing SOPs, as well as reviewing documentation and test results for accuracy, completeness, and compliance with SOPs/GMP requirements. - Coordinating with Regulatory Affairs for filing ANDAs and addressing deficiencies, providing relevant documents for ANDA filings and Supplements filing. - Reviewing batch records, process characterization reports, validation reports, and investigation reports. The required educational qualification and relevant experience for this role are: - Masters with a minimum of 13 years or a Ph.D. degree in Pharmacy with a minimum of 5 years of relevant experience in oral solids product development in the generic pharmaceutical industry. - Generic R&D experience and a successful track record of AND submissions are essential. - Experience with modified release dosage forms is a plus. - Self-motivation, excellent written and verbal communication skills, good interpersonal skills, and project management skills are critical for this position.,