David W.

❏ Well-qualified and technically proficient scientist and business development professional with 17+ years of laboratory experience and significant qualifications in pharmaceutical research, QC analytical benchwork and QMS project management. Experience with multiple FDA regulatory standards including ISO 9001, ISO 13485, and ISO 17025. ❏ Extensive experience in composing various scientific research documents: ❏ Technical reports for multiple experiments ❏ Standard operating procedures for laboratory and manufacturing equipment ❏ Quality control methods and Stability protocols ❏ Process and equipment validation packages ❏ IQ/OQ/PQ records for laboratory and manufacturing equipment ❏ Master batch records in Phase I, II, III drug manufacturing for R&D, GxP, and EU regulations. ❏ Vast knowledge and experience in the manufacturing of drug products: ❏ Solid and liquid oral dosage forms ❏ Parenteral sterile dosage forms, including lyophilization ❏ Drug-excipient interactions ❏ Formulation optimization and process development/validation ❏ Controlled release systems, emulsions, micro-encapsulations, vaccines and transdermal drug products ❏ Manufacturing multiple drug products for Phase I-III studies ❏ Experienced (6+ years) in sales and marketing activities, including daily operation with multiple CRM programs for lead generation and automated email marketing campaigns. Database management, SEO development and overall website management via WordPress. Inside/outside sales experience, including cold calling and legacy account management. ❏ Significant experience in pharmaceutical microbiology: Sterilizing and creating agar plates, Gram staining for microbial identification, Isolating various organisms for streak plating, Microscopic identification of pathogenic organisms, Environmental monitoring for detection of viable organisms in clean rooms using contact plates and air samplers. ❏ Organized, take-charge professional with exceptional follow through abilities and detail orientation; able to plan and oversee projects. EDUCATION: B.G.S. in Biology & Computer Applications, 12/2005 Ball State University, Muncie, Indiana EXPERIENCE*: Independent Consultant, 04/2015 - present Wilkerson Documentation Services, Avon, IN 46123 ❏ Freelancing via Upwork, and external business. Director of Technical Business Development, 01/2013 – 01/2017 VxP Pharma Services, 5225 Exploration Dr., Indianapolis, IN 46241 ❏ Developed website content, implemented marketing automation package. ❏ Business development activities, including hosting teleconferences, CDA placement, quote development and inside/outside sales for VxP Pharma Services. Microbiologist, 02/2012 – 09/2012 Eli Lilly & Company, 1555 S. Harding St., Indianapolis, IN 46221 ❏ Sterility testing per half-suit isolation technology. ❏ Dye Ingress testing platform implementation with validation package. Senior Research Scientist, 08/2007 – 01/2012 KP Pharmaceutical Technology Inc. 1212 W. Rappel Ave., Bloomington, IN 47404 ❏ Perform analytical testing and method development on various drug products. ❏ Assist in developing/manufacturing all types of drug dosage forms. ❏ Pre-formulation studies, dosage form development. Laboratory Technician, 08/2006 - 03/2007 Micronutrients, Inc. 1550 Research Way, Indianapolis, IN 46231 ❏ Performed daily potentiometric titrations on multiple copper solutions for Chloride, Phosphate, Sodium, and Cupric ion-concentrations. ❏ Recorded material characterization of company product by microscopy. ❏ Experience working in a fast-paced laboratory environment. Computer Laboratory Assistant, 10/2003 - 12/2003 University Computer Labs, Muncie, Indiana ❏ Provided technical support in multiple applications for students. ❏ Assisted in development of networking techniques. ❏ Conducted technical research on the university databases. ❏ Performed maintenance and organization of laboratory computers. ACTIVITIES: ❏ Scuba Recreational Open Water Diver, 1998 - Present * Further job experience and references provided upon request.