Paul Stevens Email & Phone Number

Achieved exceptional success in biopharmaceutical leadership, leveraging over 25 years of experience from lab bench to executive roles. Demonstrated expertise in talent development, fostering cross-functional team collaboration, and leading diverse professional environments. Proven track record in managing multi-national teams, overseeing third-party development projects in the U.S. and Europe, and navigating cross-company partnerships and international assignments in Germany and Puerto Rico. Articulate, personable, and results-driven leader in both large biopharma firms and start-ups.Realized consistent success in optimizing manufacturing processes and executing numerous technology transfers, scale-ups, and manufacturing campaigns for clinical and commercial stages, including process performance qualification (PPQ). Specialized in early and pivotal stage development for a diverse range of biologic modalities, such as autologous and allogenic cell therapies, guide RNA, mRNA and lipid nanoparticles (LNP), monoclonal antibodies, antibody-drug conjugates, Cas9, therapeutic proteins, and AAV vectors.Experienced in authoring and reviewing CMC sections of regulatory submissions (BLA/MAA, IND, and Briefing Book), and supporting pre-approval inspections (PAI) contributing to three commercial product approvals and three additional site licensure approvals. Notably, played a key role in the approval of the first CRISPR gene-edited therapeutic, CASGEVY™. Successfully drove new corporate sponsorship for SMDP Biotech, a non-profit career mentoring program that pairs diverse students with industry mentors. Committed to mentoring future leaders and helping all team members reach their full potential.

Listed skills include Biotechnology, Biopharmaceuticals, Cell Culture, Technology Transfer, and 31 others.