Nicholas Vrolijk, PhD

Dr. Vrolijk is a biopharmaceutical manufacturing consultant. He provides process and analytical development services, regulatory CMC support, and project management services for pre-IND through BLA development programs. He was previously with Celldex Therapeutic and was responsible for management and oversight of all internal and external manufacturing operations for production of mAbs, ADCs, and other therapeutic proteins. Previously, Dr. Vrolijk was founder and managing partner of Biopharmaceutical Product Development Services, Inc, a consulting firm that provided CMC services to a variety of small biopharmaceutical companies. Prior to that, he was with Celgene Corp., serving as Vice President of Manufacturing and responsible for supporting CMC regulatory affairs as well as the launch of Istodax®. Prior to Celgene, he was Senior VP of Manufacturing Operations at Gloucester Pharmaceuticals where he led all CMC operations for the development of Istodax®, from licensing through validation to NDA filing and approval. Dr. Vrolijk also had prior consulting experience, having been a founding partner of Pharmaceutical Manufacturing & Compliance Associates and was extensively involved in the successful development of Increlex® on behalf of Tercica, Inc. in addition to providing services to more than a dozen development companies. He previously held management positions in manufacturing operations, quality assurance, and regulatory compliance at Pharmacia Corp. and Sensus Drug Development Corp. in conjunction with the successful development and approval of Somavert®. Prior to this, Dr. Vrolijk was a Regulatory Scientist at Cato Research, a contract research organization (CRO).