Formulation And Development(Injectables)

Ciron Drugs & Pharmaceuticals; Mumbai, Navi Mumbai; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Ciron Drugs & Pharmaceuticals in Navi Mumbai seeks an experienced formulation development professional to lead a team of scientists for planning and executing parenteral and ophthalmic product development, including NDDS projects. The role emphasizes QbD-based design, literature reviews, tech transfer, and CPP oversight during scale-up.

You will coordinate cross-functional teams, review development reports for regulatory filings, and mentor colleagues while shaping development strategies and

Qualifications

• Direct and manage a team of scientists for planning and executing product development for Domestic/ROW/ANDA projects of Parenteral / Ophthalmic, Lyophilized, Liquid Injections in Ampoules, vials, PFS, Emulsions and suspensions, & Novel Drug Delivery Systems (NDDS).
• Plan detailed activities related to formulation development in line with QbD concepts and execution shall be done within targeted time limits.
• To review product literature and patent for Quantitative and Qualitative Pre-formulation studies of New Products as per Regulatory requirements.
• Formulation designing, Process optimization studies during development and support Scaleup as well as Transfer of Technology from F&D Department to Manufacturing unit.
• Understand / familiarize with the problems faced during Scale-up & Overseeing implementation of Critical Process Parameters (CPP) for Validation / Commercials at plant.
• Plan, perform and contribute to project related scientific / technical activities (e.g., interpretation of results, data evaluation, draw relevant conclusions and write reports).
• To check pharmaceutical development reports for the same and to give inputs for regulatory filings.
• To coordinate with various cross functional teams for timely meeting the F&D projects completion schedules.
• To check departmental SOPs, MFRs, Protocols and Reports related to the product.
• To guide or mentor the teammates with valuable inputs and recent developments in the pharma field.
• Interacting with machine manufacturers and review the machine design.

Responsibilities

• Direct and manage a team of scientists for planning and executing product development activity for Domestic/ROW/ANDA projects of Parenteral / Ophthalmic, Lyophilized, Liquid Injections in Ampoules, vials, PFS, Emulsions and suspensions, & Novel Drug Delivery Systems (NDDS) .
• Plan detailed activities related to formulation development in line with QbD concepts and execution shall be done within targeted time limits.
• To review product literature and patent for Quantitative and Qualitative Pre- formulation studies of New Products as per Regulatory requirements.
• Formulation designing, Process optimization studies during development and support Scaleup as well as Transfer of Technology from F&D Department to Manufacturing unit.
• Understand / familiarize with the problems faced during Scale-up & Overseeing implementation of Critical Process Parameters (CPP) for Validation / Commercials at plant.
• Plan, perform and contribute to project related scientific / technical activities (e.g., interpretation of results, data evaluation, draw relevant conclusions and write reports).
• To check pharmaceutical development reports for the same and to give inputs for regulatory filings.
• To coordinate with various cross functional teams for timely meeting the F&D projects completion schedules.
• To check departmental SOPs, MFRs, Protocols and Reports related to the product.
• To guide or mentor the teammates with valuable inputs and recent developments in the pharma field.
• Interacting with machine manufacturers and review the machine design.

Job description

Experience:- 6 - 10 Years

Location:- Navi Mumbai

Responsibilities

• 1.Direct and manage a team of scientists for the planning and execution of product development activity for Domestic/ROW/ANDA projects of Parenteral / Ophthalmic, Lyophilized, Liquid Injections in Ampoules, vials, PFS, Emulsions and suspensions, & Novel Drug Delivery Systems (NDDS) .2.Plan detailed activities related to formulation development in line with QbD concepts and execution shall be done within targeted time limits.
• 3.To review product literature and patent for Quantitative and Qualitative Pre- formulation studies of New Products as per Regulatory requirements.
• 4.Formulation designing, Process optimization studies during development and support Scaleup as well as Transfer of Technology from F&D Department to Manufacturing unit.
• 5.Understand / familiarize with the problems faced during Scale-up & Overseeing implementation of Critical Process Parameters (CPP) for Validation / Commercials at plant.
• 6.Plan, perform and contribute to project related scientific / technical activities (e.g., interpretation of results, data evaluation, draw relevant conclusions and write reports).
• 7.To check pharmaceutical development reports for the same and to give inputs for regulatory filings.
• 8.To coordinate with various cross functional teams for timely meeting the F&D projects completion schedules.
• 9.To check departmental SOPs, MFRs, Protocols and Reports related to the product.
• 10.To guide or mentor the teammates with valuable inputs and recent developments in the pharma field.
• 11.Interacting with machine manufacturers and review the machine design.