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Interface between Operations, Quality, Supply Chain Management and Purchasing ? Subject Matter Expert (SME) on multidisciplinary CMC teams to ensure scientifically driven decisions are made ? In collaboration with Quality, Regulatory Affairs, Project management and analytical groups support the CMO operations to achieve on-time manufacturing in compliance with approved dossiers ? Act as a person in Plant (PiP) at partnered site to Proactively identify and mitigate risk area impacting commercial deliveries & quality. o Interacting directly with CMO during tech transfer, campaign preparation, execution and closure including daily reporting of batch status and performance. ? Supervising technical CAPA’s resulting from ongoing investigations or manufacturing variations and partner adherence to committed regulatory approvals ? The candidate will communicate across the organization to ensure key stakeholders are aware of project status, potential risks and their required action plans. ? Perform other duties as assigned by Management. Education BE/BTech, MS or Ph.D. degree in (bio) chemical engineering, biotechnology. Professional Experience ? Doctorate degree with 1-3 years of related experience - or- Master's degree and 3-5 years of related experience - or- Bachelor's degree and 5-7 years of direct experience in Biologics GMP manufacturing ? Experience in cGMP in biologics is a must ? Experience in data handling and analysis ? Knowledge of statistical tools like minitab ? Knowledge of analytical testing methods and impact on product quality specifications is advantageous. ? Ability to diagnose complex issues; develop and implement solutions by collaborating with other teams. ? Ability to influence internal and external stakeholders through scientific justifications Skills & Abilities ? Excellent interpersonal and communication, presentation skills ? Excellent organizational and project management skills, work well under pressure. ? Ability to thrive in a small group setting with limited administrative support ? Ability to influence others, including outside of the organization, where no direct control exits. Must be able to pro-actively interact with staff, cross functional teams and external partners. ? Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Language Skills ? Fluency in written and spoken English