Principal Scientific Manager - Formulations R&D Aragen Life Sciences

5.0 - 15.0 years

0 Lacs

hyderabad, telangana

On-site

As a Formulations Scientist located in Hyderabad, India, you will be responsible for developing oral solid dosage forms of both Non-DEA and DEA substances. Your key functions will include conducting Literature Search, Pre-Formulation, and Formulation Design to ensure the development of stable, Bioequivalent, and Manufacturable generic solid oral formulations. Your responsibilities will involve being a mentor and motivator to your team. You will be tasked with developing robust formulations and processes for immediate release and modified release tablet and capsule dosage forms. Additionally, you will evaluate patents, develop non-infringement strategies, and have the capability of developing Paragraph IV products. You will be required to oversee the scale-up and optimization of the manufacturing process, execute pre-exhibit and exhibit batches, and handle the technology transfer from R&D to production to meet project timelines. Your role will also involve planning and contributing to project-related scientific/technical activities, authoring technical documents for regulatory filings, and interacting with API manufacturers, CROs, and CMOs as necessary. Furthermore, you will work collaboratively with cross-functional groups to execute change controls associated with Manufacturing and Packaging master records, SOPs, and protocols. You will be responsible for creating and reviewing SOPs, ensuring documentation and test results accuracy and compliance with SOPs/GMP requirements, and coordinating with Regulatory Affairs for ANDA filings and Supplements filing. To qualify for this position, you should hold a Masters degree with a minimum of 15 years of experience or a Ph.D. in Pharmacy with at least 5 years of relevant experience in oral solids product development within the generic pharmaceutical industry. Experience in Generic R&D and a successful track record of AND submissions are essential. Knowledge of modified release dosage forms is advantageous. Candidates should possess self-motivation, excellent written and verbal communication skills, as well as good interpersonal and project management skills.,

Posted 3 days ago

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