Formulation Research And Development Executive

Cdymax India Pharma; Jigani; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Cdymax India Pharma in Jigani, Karnataka seeks a formuation and development expert to drive robust formulation, lab scale work, scale-up and technology transfer for finished drug products and global launches.

The role involves creating and reviewing IP-related reports, literature and patent searches, pre-formulation studies and QbD-based development in line with FDA/ICH guidelines, with a focus on achieving target quality attributes.

Qualifications

• M. Pharm. degree required.

Responsibilities

• Responsible for development of robust formulation and process to deliver high quality products within the specified timelines by utilizing available resources in best manner.
• Responsible for characterization, lab scale development, scale-up, technology transfer and scale-up operations to manufacture the finished drug products.
• Conducting day-to-day execution of R&D development trials, achieving desired critical quality attributes and manufacturing the stability batches and bioequivalent batches.
• Preparing and reviewing the summary report of IP review of the new molecule to bypass the innovator patents for NCE-1, Para-IV and 505b2 filing.
• Responsible for Literature search, patent search, Pre-formulation studies and preparing the literature review presentation of selected new molecules.
• Applying QbD principles as an integral part of formulation development as per FDA/ICH guidelines.
• Analyzing and reporting the data accurately in a clear and concise manner: suggesting conclusions and recommendations.
• Reviewing and closing of final prototype formulation, which is closet in behavior to the innovator drug.
• Preparing product review presentations of the formulation development.
• Procurement of raw materials, packaging materials and innovator product from different vendors for selected finalized projects.
• New product development planning for global markets (China/EU/US/WHO).
• Giving SOP training and external training to all departmental employees and adhering to the health and safety polices, keeping the lab and laboratory equipment clean
• Responsible for review of Lab note books, product development report and protocols (Stability/Hold time study etc.) and manufacturing records (Maser formula card, Master packing card etc.)
• Coordinating with cross functional teams for smooth execution of projects to meet project timelines
• Drafting QTPP for the selected products and formulation strategies to achieve target attributes

Education

M. Pharm.

Job description

Role & responsibilities

• 1. Responsible for development of robust formulation and process to deliver high quality products within the specified timelines by utilizing available resources in best manner.
• 2. Responsible for characterization, lab scale development, scale-up, technology transfer and scale-up operations to manufacture the finished drug products.
• 3. Conducting day-to-day execution of R&D development trials, achieving desired critical quality attributes and manufacturing the stability batches and bioequivalent batches.
• 4. Preparing and reviewing the summary report of IP review of the new molecule to bypass the innovator patents for NCE-1, Para-IV and 505b2 filing.
• 5. Responsible for Literature search, patent search, Pre-formulation studies and preparing the literature review presentation of selected new molecules.
• 6. Applying QbD principles as an integral part of formulation development as per FDA/ICH guidelines.
• 7. Analyzing and reporting the data accurately in a clear and concise manner: suggesting conclusions and recommendations.
• 8. Reviewing and closing of final prototype formulation, which is closet in behavior to the innovator drug.
• 9. Preparing product review presentations of the formulation development.
• 10. Procurement of raw materials, packaging materials and innovator product from different vendors for selected finalized projects.
• 11. New product development planning for global markets (China/EU/US/WHO).
• 12. Giving SOP training and external training to all departmental employees and adhering to the health and safety polices, keeping the lab and laboratory equipment clean
• 13. Responsible for review of Lab note books, product development report and protocols (Stability/Hold time study etc.) and manufacturing records (Maser formula card, Master packing card etc.)
• 14. Coordinating with cross functional teams for smooth execution of projects to meet project timelines
• 15. Drafting QTPP for the selected products and formulation strategies to achieve target attributes

Preferred Male candidate OSD profile :

Department: Formulation and Development

Education Qualification: M. Pharm.