Sudheer Sami

Background

About Sudheer Sami

My expertise lies in Product/Process Development, Process engineering, Validation, and Project Management. I am a dynamic and versatile professional with over 13 years of experience in Biotech and Pharma industry. I am adept at combining technical knowledge and personal drive to develop and improve processes and methods. I have led mission-critical R&D and process scale-up and tech transfer efforts. I enjoy organizing teams and resources to guide development and implementation, and am a persistent researcher, comfortable troubleshooting/resolving problems and liaising between business and technical stakeholders to ensure commercially viable designs, processes, and concepts. A hands-on project manager and advisor, I seek continuous improvement in the biologics/pharma drug development process. I have extensive scale-up experience, having succeeded at guiding technologies from the lab to commercial operation. I work well with vendors, contractors, clients, and contract manufacturers to drive projects, and am able to build and lead cross-functional teams on internal and external stakeholders, effectively aligning contributions from geographically dispersed teams to achieve on-target deliverables. SPECIALTIES: MSAT, Regulatory Compliance; Project Management; Process Development & Scale-Up; Statistical Process Control; Problem Solving; Budgeting; Data Analysis; Trending; Technical Mentorship; Sourcing; Lyophilization Process; Team Leadership; Cross-Functional Projects; Vendor Management; Industry Best Practices; Resource Management