Executive - R&D (API)

Role Overview

This position involves extensive process development for new Active Pharmaceutical Ingredients (APIs) and their intermediates, focusing on optimizing production routes, ensuring safety, and regulatory compliance.

Key Responsibilities

• Develop new processes for APIs and intermediates, including cost-effective and safe synthesis routes.
• Manage technology transfer activities and validate processes at manufacturing plants.
• Conduct comprehensive literature and patent searches to support molecule development and avoidance of infringement.
• Plan, execute, and optimize experimental reactions, analyzing trial results to enhance processes.
• Design specifications for starting materials, in-process tests, intermediates, and final APIs.
• Identify critical parameters and implement Quality by Design (QbD) principles in process development.
• Develop and evaluate various polymorphs and interpret related analytical data using NMR, Mass Spectrometry, IR, DSC, and TGA techniques.
• Prepare detailed Technology Transfer Documents and support troubleshooting including investigations of Out-of-Specification (OOS) or Out-of-Trend (OOT) results with corrective and preventive actions.
• Develop and implement reprocessing methods for OOS batches to minimize waste.
• Assist vendor development by conducting trials on Key Starting Materials and maintaining coordination with the Analytical Development Lab.
• Provide regular reporting, document experiments meticulously in Lab Notebooks, and support departments such as QA, Regulatory Affairs, Marketing, and others for technical queries and data sharing.
• Evaluate APIs for impurity profiles including genotoxic and nitrosamine impurities, providing crucial data to QA teams.
• Lead initiatives for cost reduction and process improvements of existing APIs.
• Oversee solvent recovery and recycling processes at manufacturing sites.
• Collaborate closely with cross-functional teams including Production, QC, QA, Regulatory Affairs, Marketing, Finance, HR, and Environmental Health & Safety.
• Travel as needed to Contract Manufacturing Organization (CMO) locations for technology transfer and support.
• Maintain lab organization and ensure thorough documentation practices.

Required Skills and Knowledge

• Expertise in process development for APIs and their intermediates.
• Knowledge and application of CGMP, GLP, and relevant regulatory guidelines.
• Strong literature and patent research capabilities using internet and specialized databases like SciFinder.
• Ability to plan, execute, and analyze process experiments systematically for optimization.
• Experience with analytical characterization techniques such as NMR, Mass Spectrometry, IR spectroscopy, DSC, and TGA.
• Capability to prepare comprehensive documentation including Technology Transfer Documents and Lab Notebooks.
• Competence in troubleshooting plant issues and developing CAPA strategies.
• Coordination skills to work effectively with multiple functional teams and vendors.