A dynamic, results-driven pharmaceutical leader with 20+ years of global experience in development and technical transfer operations, specializing in small molecule drug product development, tech transfer, product validation, filing, and commercial manufacturing.
Proven success in driving complex products from development through to commercialization. Adept at leading cross-functional teams and external partners to execute integrated strategies that ensure high-quality outcomes and successful regulatory submissions.
Known for strategic decision-making, building high-performance teams, and managing large-scale projects.
Key Expertise:
• Small Molecule Drug Product End-to-End Development: Led the development, scale-up, and tech transfer of 40+ pharmaceutical products, including long-acting injectables, oral solids (including ERs), topicals, and combination products employing Quality by Design (QbD), process validation, and control strategy; managed teams up to 35 members.
• Cross-Functional Leadership: Directed and managed teams and projects in development, clinical operations, manufacturing, quality, and regulatory to achieve project milestones and solve complex development and manufacturing challenges.
• Strategic Operations & External Partnerships Management: Project management of portfolios, vendors (CDMO & CTL), tech transfers, and product lifecycles across multinational and virtual companies, from asset creation to successful commercialization.
• Regulatory CMC Submission Expertise: Extensive experience in reviewing and approving global regulatory pre and post submissions (IND, NDA, ANDA) and ensuring compliance in USFDA and EMA markets.
• Compliance Experience: Led several development audits and as an SME faced facility and PAI audits; Expertise in ISOs, ICH (Q1, Q6-Q13), USP/Ph.Eur, cGMPs (parts 4, 210, 211), SUPAC guidelines.
• Process Excellence & Cost Reduction: Executed Six sigma, lean manufacturing projects for value creation; DOE, stability/shelf-life analyses, control charts, specification settings, manufacturing in-process analyses, sampling plans; trained green & yellow belts.
Veritux independent consultants are available where you need them – in all major markets and every global region.
