Manager Process Research Development (R&D),Ankleshwar

Search Advisers Services Guj; Ankleshwar; On-site; INR 600,000 - 900,000; Full time

Job summary

Search Advisers Services Guj in Ankleshwar, Gujarat, invites a skilled process development scientist to drive API projects from discovery to scale-up. You will conduct literature searches, finalize synthetic routes, and transfer technology from lab to plant, ensuring robust documentation.

You will identify impurities, coordinate materials, perform stability studies, and prepare PDR, TTD, and scale-up reports while complying with safety rules.

Responsibilities

• Conduct literature search and finalize synthetic routes for assigned API projects.
• Develop, optimize, validate, and scale up chemical processes from lab to plant.
• Prepare and review tech documents including Technology Transfer Documents (TTD), PDR, Scale-up Reports, and Investigation Reports.
• Develop, identify, and characterize product-related impurities.
• Coordinate raw material procurement and maintain inventory for R&D activities.
• Perform stability studies for development, scale-up, and validation batches before technology transfer.
• Evaluate literature and prepare cost analyses for new and existing molecules.
• Support regulatory submissions by addressing FDA/DMF deficiencies and preparing technical documentation for regulatory authorities.
• Ensure compliance with safety standards, MSDS guidelines, and process safety requirements.
• Lead, mentor, and manage a team of scientists to achieve project timelines and organizational objectives.

Job description

Role & responsibilities

• Conduct literature search and finalize synthetic routes for assigned API projects.
• Develop, optimize, validate, and scale up chemical processes from lab to plant.
• Prepare and review technical documents including Technology Transfer Documents (TTD), Product Development Reports (PDR), Scale-up Reports, and Investigation Reports.
• Develop, identify, and characterize product-related impurities.
• Coordinate raw material procurement and maintain inventory for R&D activities.
• Perform stability studies for development, scale-up, and validation batches before technology transfer.
• Evaluate literature and prepare competitive cost analyses for new and existing molecules.
• Support regulatory submissions by responding to FDA/DMF deficiencies and preparing technical documentation for regulatory authorities.
• Ensure compliance with safety standards, MSDS guidelines, and process safety requirements.
• Lead, mentor, and manage a team of scientists to achieve project timelines and organizational objectives.