GM

Job Description : GM R&D API VANCOUVER CANADA Open to International candidates Experience: 20+Years Qualification: Ph.D. / M.Sc. (Organic Chemistry) with strong API Process R&D experience. Lead the API Process R&D function by driving the development, optimization, scale-up, and commercialization of cost-effective, robust, and regulatory-compliant manufacturing processes for Active Pharmaceutical Ingredients (APIs). The role involves managing multiple development projects, mentoring the R&D team, and collaborating with cross-functional departments to ensure timely delivery of projects. Key Responsibilities * Lead API process development from laboratory scale through pilot plant, technology transfer, and commercial manufacturing. * Develop innovative, non-infringing, cost-effective, and scalable synthetic routes. * Optimize processes to improve yield, quality, productivity, and manufacturing efficiency. * Plan, review, and monitor R&D projects to meet timelines and business objectives. * Ensure compliance with cGMP, ICH, FDA, EMA, and other global regulatory requirements. * Review technical documents including development reports, batch records, specifications, risk assessments, and regulatory documentation (DMF/CEP support). * Provide technical guidance during technology transfer, process validation, and commercial manufacturing. * Investigate process-related deviations, OOS, CAPA, and implement continuous improvement initiatives. * Collaborate with Analytical R&D, Production, QA, QC, Regulatory Affairs, Supply Chain, and EHS teams. * Mentor and develop scientists, managers, and research associates within the R&D department. * Evaluate new technologies, green chemistry approaches, and process intensification opportunities to enhance competitiveness. Required Skills * Strong expertise in API Process R&D and scale-up. * Thorough knowledge of synthetic organic chemistry and process optimization. * Experience in technology transfer and commercialization. * Hands-on knowledge of cGMP, ICH guidelines, USFDA, EDQM, PMDA, and other global regulatory expectations. * Strong project management and people leadership skills. * Excellent analytical, troubleshooting, communication, and decision-making abilities. Key Performance Indicators (KPIs) * Successful development and commercialization of API processes. * Timely completion of R&D projects. * Improvement in process yield and cost reduction. * Successful technology transfers with minimal manufacturing issues. * Regulatory inspection readiness and compliance. * Team productivity and capability development.

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