Prior to IBA Molecular, Lee spent four years with AAIPharma Services where he was hired to reestablish the CDMO from bankruptcy and did so culminating in a successful $50MM sale to a private equity firm in 2009. Mr. Karras also spent 15 years with Cook Pharmaceutical Services and then Baxter Biopharma Solutions managing those successful CDMO businesses helping build the Baxter business into an a $200MM+ business during his tenure.
Lee has a proven track record of building scalable, yet cost effective businesses as well as managing complex contract research, manufacturing and pharmaceutical services businesses. Having worked in the contract pharmaceutical services industry over the last two decades, Lee has had to adapt and develop new business models to keep pace with the ever changing pharmaceutical landscape.
Lee holds a bachelors degree in Chemistry and an MS in Environmental Science, both from Indiana University in Bloomington.
Mr. Lederman also spent 10 years with Roche in positions of increasing responsibility within Finance, culminating in his appointment as Senior Vice President – Head of Business Analysis and Controlling at Roche Centralized Diagnostics, headquartered in Mannheim, Germany.
Mr. Lederman holds a Master of Business Administration with a dual concentration in Finance and Operations Management from the University of Rochester – Simon Business School and a Bachelor of Science degree in Electrical Engineering from the University of Rochester. In addition, he is a certified public accountant licensed in New Jersey and New York and gained his accounting experience at PwC. He also serves as a board member with the Northern New Jersey Council of the Boy Scouts of America.
Prior to joining Halo, Maryse has worked in numerous roles in the pharmaceutical industry. Her most recent assignment was in the Global Technology Organization of Merck to support more than 35 external partners around the world producing consumer care products. Previously, Maryse was the Technical Service Director at Merck Canada site. She managed as GTO Director, the plant expansion, the installation and qualification of utilities, process and packaging equipment. Maryse was also involved in the transfer of multiple products in the Merck network. Maryse also supported the Schering Plough Canada site as Director of Production and Director of Quality Unit.
Maryse has a deep knowledge of EMEA, FDA, JP and HPFBI regulations. She has led numerous internal audits from different regulatory agencies and external manufacturing site audits for critical suppliers.
Maryse has a Master Degree in Biochemistry from the University of Quebec in Montreal, Canada. She is co-writer on several scientific publications and co-author on two patents.
Prior to joining Halo, Jim has worked in numerous roles in the pharmaceutical industry. His most recent assignment was at Fougera Pharmaceuticals where Jim held roles of Executive Director of Manufacturing Technology and Vice President of Manufacturing. He was responsible for commercial manufacturing and support activities at two discrete manufacturing sites. Previously, Jim was the Vice President of Manufacturing for Bradley Pharmaceuticals where he managed development, tech transfer, inventory, and manufacturing activities at multiple CMO’s and CDMO’s. Jim spent a major portion of his career at PF Labs (Purdue Pharma) gaining experience in all facets of production operations for liquid, semi-solid and solid dose formulations.
Jim has a deep knowledge of FDA, DEA and OSHA regulations. He has led numerous projects including new product launches, implementation of Manufacturing Execution Systems, ERP systems, equipment and facility expansions.
Jim is a New Jersey, Registered Pharmacist with a BS in Pharmacy from Rutgers University.
Prior to Patheon, Dr. Qu was Vice President, Scientific Affairs at Apotex, where he was responsible for managing the departments responsible for Formulation development, Analytical development, Regulatory affairs and Laboratory technical services.
Dr. Qu received his Bachelor and Master Degrees from Western China University of Medical Sciences in Medical Science. He earned his PhD from the University of Toronto in Biochemical Pharmacology. In addition, Dr. Qu holds several patents, and has published three books and more than a dozen scientific papers and abstracts.