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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