Aaron Karlin

WORK HISTORY

EDUCATION

SKILLS

ABOUT AARON KARLIN

I am an experienced Project Manager with a deep understanding of pharmaceutical project lifecycle management, regulatory strategy, and technical transfer processes. Skilled at leading cross-functional teams to deliver complex drug products on time and within budget, ensuring regulatory compliance and improving patient outcomes. Proven expertise in CDMO/CMO collaboration, project planning, and implementing process improvements for greater efficiency and quality.What I Bring to the Table• I deliver end-to-end project management for timely, budget-conscious delivery, from early-stage development to commercialization.• I have extensive knowledge of FDA submission processes (IND, NDA, ANDA, BLA) to support seamless market entry and lifecycle management.• Strategic Partnerships: I am skilled at leveraging strategic partnerships (CDMO and CMO) to optimize technical transfer and clinical trial management, achieving milestone alignment and operational efficiencies.• I have implemented KPIs, developed PowerBI reports, and championed AI-driven solutions to improve project visibility and informed decision-making.• I cultivate high-performing teams by mentoring in best practices, risk management, and technical expertise to promote growth and project excellence.What Sets Me Apart• I have over a decade of hands-on experience across multiple stages of drug development, from R&D through scale-up and commercial launch.• I am PMP-certified with a strong engineering background, including sterile injectables expertise, aseptic cleanroom design, and equipment validation.• I am skilled in optimizing processes through LEAN and Six Sigma methodologies, managing complex supply chain challenges, and minimizing risks in high-stakes environments.• I have successfully led high-impact projects for industry leaders such as Pfizer, Thermo Fisher, Bayer, and Unilever, enhancing project outcomes and ensuring compliance. Key Skills Regulatory • Project Management (PMP Certified) • Clinical Trial Management • LEAN & Sigma Six Methodologies • Pharmaceutical Process Scale-Up Validation • Risk Assessment & CAPA Implementation • CDMO/CMO Partnership Management • Supply Chain Optimization • End-to-End Drug Development • Cross-Functional Leadership • Stakeholder Engagement • Aseptic Cleanroom Design