President

Job Description : President /Sr VP - New Product Development (NPD) APIs & Intermediates Role - Developing Non-Infringing, Cost Effective, Robust, Safe, & Scalable processes As Per Current Regulatory Guidelines for Highly Regulated Markets, Effective Management of Analytical Research & Development & Overall Responsible for Process Research (API) Development of Generic API for New DMF/ASMF/CEP filings Across Global Markets Role Description/Requirements In-Depth Knowledge of Multi-Step Synthesis Process Development for Complex Organic Molecules. Experience in Synthesis of Peptides & Prostaglandins will be Added Advantage Experience in Designing & Setting up an R&D Labs, Teams Hands on experience in Managing End–to-end Process Development with Cross Functional Team Members Under in a Project Managed Environment Conducting Root-Cause Analysis for various issues Arising During Scale-up, Validation, Manufacturing with hands on Experience in Shooting and CAPA Management. Supporting Regulatory Affairs in Acquiring various Regulatory Market Compliance as Required, Preparation of Documents for Regulatory filing & Audit. Providing Technical Support for existing Product Troubleshooting, Process improvement, Optimization & yield Improvement, Cost Reduction. Development of New Molecules of API for DMF Filing, Execution of Pre-Scale Up, Scale Up & Exhibit / Validation Batches of the New Products Scale-Up & Technology Transfer from lab Scale to Kilo lab, Pilot Plant Scale & finally to Plant Scale for Commercial Production. Conversant with Particle Technology & Solid-State Characterization of APIs Exposure to DOE, Parallel Synthesis & Green Chemistry Principles Articulate, Dynamic leadership With Diverse Blend of Process R&D / Process Improvement / Process development, Tech transfer, Scale-up Expertise of API & Transformative leader with Excellent Communication, Interpersonal & Analytical Skills; Capable of Motivating, Mentoring & Training Research Teams to Deliver Optimum Performance. Qualification: M.Sc.PhD.with About 25+ Years of Experience Skills & Expertise Possess Knowledge of Modern Analytical Techniques Well Versed with ICH Guidelines, cGMP, USFDA Regulatory norms Hands on Experience in Managing a team of 50-100 Scientists. Ability to Drive Multiple Projects (NPD) with Stringent Timeline. Excellent Communication, leadership, Interpersonal Skills. Exposure to Customer Interfacing Strong Problem Solving, Eye for Details, Analytical Abilities Strategic Thinker with Result-Oriented Approach

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