William Remis Email & Phone Number

Representing several prominent staffing firms for short term, ad-hoc consulting sessions focusing on early stage formulation development, pre-clinical safety, efficacy, and tox studies, and regulatory and quality compliance with foreign and domestic pharmaceutical and specialty chemical comanies . Familiar with 21CFR parts 58, 210, 211, 4, and 820.

Midwest

Global Supplier of lipid based pharmaceutical excipients with expertise in drug delivery solutions including bioavailability enhancers, sustained release vehicles, solubilizers, emulsifiers, lubricants, and taste masking agents for oral and topical drug delivery formulations. Project Leader. Hired to meet specific strategic intent objectives in the Midwest Territory by managing new and existing customer drug formulation projects through a consultation process of identifying drug delivery issues and providing solutions for solubility, intestinal absorption, and bioavailability enhancement. Utilized company PM planning tools to drive project oversight management. Prepared dossiers by compiling quality, regulatory, safety, toxicology, stability, DMF, and CoA documentation to demonstrate that customer requirements and regulatory guidelines have been met for each product.

Developed and managed market penetration projects for North America to jump start the introduction of a pharmaceutical capsule product portfolio from a foreign base of operations. Implemented name recognition tactics through participation in key trade shows and developed promotional materials for inclusion in key trade journals. Generated a key-target list and initiated a calling cycle to penetrate new accounts through the establishment of R&D projects. Orchestrated major presentations to key scientists and purchasing agents at large Rx, ANDA, Dietary Supplement, and CMO companies to highlight the quality and economic benefits of the company's value chain including capsule and machinery product lines.

Led the North American market development and sales growth of Pharma/Nutritional ingredient and Fermentation Substrate business in the United States, Canada and Mexico by driving the direct sale of specialty products to companies in these countries. Selected, trained and directed channel marketing partners in Mexico and Puerto Rico.Orchestrated Marketing and Sales across multiple Cargill divisions while addressing the needs of more than 100 accounts throughout North America. Evangelized Cargill’s existing and future product lines by developing long term supply agreements for product development including clinical trials with the largest Pharmaceutical and Medical Nutrition companies in the U.S.Created high impact collateral marketing materials and booth graphics to highlight the value proposition of the company's pharma grade product offerings.

Keokuk, Iowa

Drove the development and expansion of Roquette's Specialty Pharma Ingredient business by providing consultative solutions oriented services to its pharmaceutical and fermentation customers in the U.S., Mexico, Thailand and Malaysia. Collaborated with sales, regulatory, and quality groups to formulate and execute strategic customer-driven marketing projects aligned with Roquette's overall sales objectives for its specialty excipient portfolio.

An investor backed entrepreneurial Pharmaceutical Research and Development Company that developed patented drug delivery technologies for Ethical Pharmaceuticals including Transdermal, Topical, Sublingual, and Iontophoresis platforms.Recruited by the CEO to guide this startup company's operations in facilities management, equipment procurement and operation, and all Pharmaceutical development work. Provided essential Business Development support by developing the strategic plans behind it as well as fund raising to ensure financial stability during a period of early stage development and growth.Set the foundation for effective product development and marketing by managing projects dedicated to these activities.Designed and supervised construction of R&D laboratories. Authored IND for topical drug delivery product, approved by FDA for phase I clinical trials.Negotiated licensing arrangements with major pharmaceutical companies.Secured $3M in investment by launching the successful negotiation of equity financing with a Venture Capital firm.

Recruited by senior management to revitalize an unorganized and troubled territory sales operation. Refocused and refined sales efforts by organizing the territory into market segments based on product and customer type to better focus related advertising campaigns.

Round Lake, Illinois

Early career success as Senior R&D Supervisor.Progressed to increasingly higher levels of responsibility from research pharmacologist to Sr. Supervisor in the Pharmacology/Bioengineering section. Designed and managed all large and small animal surgery procedures for preclinical product development projects. Coordinated and managed the activities of up to 15 direct reports for assigned safety, toxicology, efficacy, and bio engineering projects. Managed the successful execution of assigned R&D programs leading to market introduction of a variety of medical devices, intravenous solutions, and pharmaceutical products with strict adherence to GLP guidelines and Good Documentation Practices. Authored standard operating procedures and maintained departmental SOP data base. Recipient of Outstanding Technical Achievement Award in Nutritional Biochemistry for Total Parenteral Nutrition project.

Mba, Business Administration

With Honors

B.A., Physiology/Chemistry

Area of concentration: Medical Physiology, Pharmacology, and Biophysics.