Assistant Manager - Formulation Development Rubicon Research Limited

3.0 - 7.0 years

0 Lacs

thane, maharashtra

On-site

As a Product Development Manager, you will be responsible for developing new products and optimizing existing formulations for various dosage forms such as Tablets, Capsules, Solutions, Suspensions, Pellets, MUPS, etc. Your primary focus will be on regulated markets like the US, Europe, and ROW. Key Responsibilities: - Define project scope, activities, and timelines, and monitor progress to ensure timely completion. - Lead the development of new formulations by investigating API characteristics, safety, and compatibility with other ingredients, conducting necessary testing, and scaling up studies. - Identify resource requirements, including materials, manpower, and machinery, and utilize literature information effectively throughout development. - Develop R&D plans and experimental designs using QBD principles, analyze data, draw conclusions, and make recommendations for product development. - Coordinate lab scale-up and pilot BE batches, ensuring adherence to lab GMP practices. - Review lab experiment notebooks and technology transfer documents promptly. - Liaise with technology transfer and production teams for seamless technology transfer and review batch manufacturing and process validation documents. - Optimize existing product performance by researching API characteristics and formulas. - Monitor stability studies, interpret results, and advance product development accordingly. - Coordinate with various departments to ensure timely project completion. - Prepare departmental SOPs, manuals, and guidelines as required. - Monitor machine IQ, OQ, and PQ activities, ensuring proper functioning and maintenance. - Provide training to subordinates, technicians, and housekeeping personnel on equipment and systems. - Manage storage and destruction of raw materials and finished goods and maintain RLD samples inventory. - Participate in audits and ensure compliance with recommendations. - Stay updated with the latest developments in technology, conceptual thinking, and communication skills. Qualifications & Pre-Requisites: - Master's in Pharmacy (Pharmaceutics). - Must-Have Skills: Formulation development experience in Solid & Liquid Oral; Pellets project experience preferred. Additional Company Details: - The role may require working extended hours or shifts based on requirements. - Visits to manufacturing sites may be necessary. (Note: The additional notes section has been included as an "Additional Company Details" paragraph in the final JD),

Posted 4 days ago

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