Mark Einziger

Development of Project Management team for Pharmaceutical Industry

IT

Manager external and internal Pharmaceutical development projects at major CRO Manager multi-discipline cross-functional teams, from project inception to technical transfer to production. Develop strategic planning and aggregate project scheduling for timely completion of customer projects Maintain project revenues to ensure timely completion of project tasks Develop project timelines on twelve current project, with revenue of $130K - $2.0MM per project Main contact with customer both internal and external, setup and conduct weekly update meeting on all active projects. Responsible for maintaining meeting minutes and action items

Manage commercialization and new product development group for Specialty Product Division. Regulatory Created and wrote SOP's, DMR (Device Master Record), DHF (Device History File), Risk Analysis, Gap Analysis and FDA filing with regulatory and compliance group regarding medical devices regulations. Sited, audited and validated outside contract manufacturing for medical device product production.

Lead medical device projects focusing on Hemodialysis

Directed both medical and non-medical product development including, Hemodialysis products, Commercial and Professional product lines, Microdermabrasion products and Ostomy deodorizer's products. Supervised all technical aspects for sodium bicarbonate in the dialysis, pool and spa industry. Implemented the training of 5 laboratory associates in generating technical data to maintain Church & Dwight's 95% US market share for dialysis bicarbonate. Page 2 MARK EINZIGER Formulated new pool chemicals including "Clear Balance" tablets and granular material for the control of pool water's alkalinity and pH. U.S. Patent granted. Devised innovative delivery systems for chemical formulations use in residential and commercial pools. Set-up in-house and field pool studies, including stabilize studies and consumer test panels. Design field study protocol for sodium bicarbonate pool products for patent and marketing claims. Accountable all technical requirements for sodium bicarbonate additives for food group specializing in new levening technology. Major customers include General Foods, Kraft and Nabisco Foods. Traveled worldwide as technical representative for dialysis programs. * Represent Church & Dwight at technical and trade shows in the dialysis industry. Develop custom sodium bicarbonate granulation cuts for revolutionary dialysis delivery systems. RHODIA formally RHONE POULENC

Plant manager responsible for the daily production. Supervised research and development group, purchasing and packaging for a private label manufacturing company. Accountable for customer contact and sales. Conducted research and development in the production of semi-solids and solid dose products. Conducted research and development in the production of liquid and semi-solid surfactants for the cosmetic industry, as well as general household cleaners sold under the Amway label. Manufactured all creams, and lotions, shampoos and cleaning products. Purchased equipment and chemicals and sourcing of new vendors.