Senior Vice President
Job Description
Principal task and Responsibilities:•Provide strategic leadership across all R&D verticals: Synthetic Labs, ADL, PERL. Process Development (Plant), and Tech Transfer.
• Drive new product development, route scouting, process optimization, scale-up, and regulatory- compliant documentation for DMF filing.
• Ensure robust analytical development, including method development, method validation, and impurity profiling, and advanced characterization.
• Oversee technology transfer activities to pilot and commercial plants, ensuring smooth implementation and continuous improvement. Ensure compliance with data integrity, EHS, and global regulatory requirements for API development.
• Coordinate closely with Regulatory Affairs, QA, QC, and Manufacturing to support DMF submission and commercial readiness.
• Strengthen capabilities across R&D through leadership, mentoring, and fostering scientific excellence. Responsibilities: Synthetic R&D Labs Oversee route selection, feasibility, process optimization, and scale-up readiness. Approve experimental plans, safety assessments, TTDs, and development reports. Ensure robust, scalable, and cost-effective API processes for NPD and CIP projects. Analytical Development Lab (ADL –GCMS/LCMS/XRD) Lead analytical method development and method validation for APls, intermediates, impurities, and raw materials. Guide impurity profiling, structural elucidation, residual solvent studies, polymorph characterization, and stability programs.
•Provide analytical support to plant for Nitrosamine, Genotoxic impurities (GTIs), and Elemental Impurities (EIs) testing as required.
•Approve analytical protocols, validation reports, and data packages regulatory submissions. -Process Engineering Research Lab (PERL)
•Review engineering and scale-up data, process modelling, equipment suitability, and reactor parameter definitions,
•Align PERL activities with PD and Tech Transfer requirements for plant implementation.
•Support process robustness studies, risk assessment -Process Development Lab (Plant) & Tech Transfer Team
•Ensure readiness for pilot and commercial-scale batches, including protocols, safety dossiers. engineering inputs.
•Review plant trial data, troubleshoot deviations, and optimize process parameters.
•Approve final tech transfer documents, control strategies, and CPP/Design Space elements. -Regulatory & DMF Support
•Ensure complete and compliant documentation packages for DMF submissions, including analytical, process, and validation data.
•Support RA in query responses and CAPA-driven improvements. -CIP (Continuous Improvement Projects)
•Drive yield improvement, cost reduction, impurity control, and process simplification initiatives.
•Prioritize high-impact projects aligned with business and manufacturing needs. -Leadership, Compliance & Governance -Conduct technical daily meeting, review meetings, Lab Seminar, Weekly departmental Seminar -Mentor Group Leaders, ensure team competency, and build technical depth across R&D. -Establish project tracking dashboards, KPIs, and performance reporting systems. -Maintain strong EHS culture across all labs; ensure safe chemical handling,