Dr. Lambert has 20+ years of experience in drug and device development. His experience includes device/drug combination products, vaccines, monoclonal antibodies, recombinant proteins, peptides and small molecules for parenteral, pulmonary, solid oral, topical and transdermal dosage forms. He has expertise in Quality by Design with specific emphasis on designing and leading Risk Based QbD activities for ANDA, NDA, BLA, PMA and MDD applications. He has executive leadership experience and expertise in CMC strategies small, large, and complex large molecule modalities and in developing, formulations, processes (upstream and downstream) and analytical methods for products at all phases of drug and device development lifecycle.
Dr. Lambert’s participation in academic/industry/regulatory agency collaborations throughout his career has resulted in multiple grant awards supporting the development of novel products and therapeutics. He has unique experience in having supported both development and commercial manufacturing on the drug/product sponsor side of the development process as well as from a contract service provider’s perspective. He continues to apply his industry knowledge and thought leadership to support innovative market approvals for novel technologies.