Formulation Research And Development Executive

Cdymax India Pharma; Jigani; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Cdymax India Pharma seeks a skilled formulation development professional to lead robust development programs, scale-up processes, and technology transfers in line with regulatory guidelines. The role involves coordinating with cross-functional teams, performing literature searches, and preparing development reports.

The candidate will drive IP review activities, ensure product quality targets, and contribute to global product strategies while adhering to health and safety policies within the R&D

Qualifications

• Experience in formulation development and process development.
• Knowledge of FDA/ICH guidelines and regulatory expectations.
• Ability to perform literature and patent searches to support development.

Responsibilities

• Develop robust formulations and processes to meet timelines with optimal resource use.
• Characterize, scale-up, transfer technology, and manufacture finished products.
• Conduct development trials, ensure critical quality attributes, and prepare stability/bioequivalence batches.
• Prepare and review IP-related reports and literature reviews for new molecules.
• Apply QbD principles in formulation development per FDA/ICH guidelines.
• Analyze data, report results clearly, and propose conclusions.
• Coordinate with cross-functional teams to ensure timely project execution.
• Draft product review presentations and SOP trainings for department.

Skills

Formulation development

QbD principles

Technology transfer

Scale-up

Cross functional coordination

Literature review

Regulatory awareness

Education

M. Pharm.

Job description

Role & responsibilities

1. 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. 2. Responsible for characterization, lab scale development, scale-up, technology transfer and scale-up operations to manufacture the finished drug products.
3. 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. 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. 5. Responsible for Literature search, patent search, Pre-formulation studies and preparing the literature review presentation of selected new molecules.
6. 6. Applying QbD principles as an integral part of formulation development as per FDA/ICH guidelines.
7. 7. Analyzing and reporting the data accurately in a clear and concise manner: suggesting conclusions and recommendations.
8. 8. Reviewing and closing of final prototype formulation, which is closet in behavior to the innovator drug.
9. 9. Preparing product review presentations of the formulation development.
10. 10. Procurement of raw materials, packaging materials and innovator product from different vendors for selected finalized projects.
11. 11. New product development planning for global markets (China/EU/US/WHO).
12. 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. 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. 14. Coordinating with cross functional teams for smooth execution of projects to meet project timelines
15. 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.