Formulation And Development Executive

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

Job summary

Cdymax India Pharma is seeking a formulation and development professional to drive robust product development, scale-up, and technology transfer. The role covers lab-scale development, trial execution, and documentation to ensure quality and regulatory compliance.

The candidate will apply QbD principles per FDA/ICH, review literature and IP, and coordinate with cross-functional teams to meet project timelines. M. Pharm. is preferred and prior experience in pharma R&D is desirable.

Qualifications

• M. Pharm. degree is required.
• Strong formulation development and QbD knowledge.
• Experience with FDA/ICH guidelines.

Responsibilities

• Develop robust formulations and processes to deliver high-quality products.
• Conduct lab scale development, scale-up, and technology transfer.
• Execute R&D trials and prepare stability/bioequivalence batches.
• Review IP literature and prepare patent/ literature reviews.
• Apply QbD as part of formulation development per FDA/ICH.
• Analyze data and present clear conclusions.
• Coordinate with cross-functional teams to meet timelines.
• Prepare product reviews and SOP/training material.

Skills

Formulation development

QbD principles

Technology transfer

FDA/ICH guidelines

Data analysis

Cross-functional coordination

Lab report writing

SOP training

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.