Pharmaceuticals, Medical Device, Business Management, USFDA, Chemistry Expert Consultant Resume
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Resume of MMT
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• Pharmaceuticals and Medical Devices
• Chemical and Laboratories
• Certifications and Regulations

BS in Chemistry from Baylor University in Waco, TX

This consultant is a skilled executive with much experience: 27 years in a USFDA regulated environment, 22 years of pharmaceutical and medical device work, and 20 years of management experience in industry, business, project management, quality, validation, and regulatory affairs. He has managed project teams in excess of 250 people, managed scientific teams of 32 people ranging in experience from B.S. to Ph.D., managed direct personnel with functions that included raw material, in-process, finished product, toxicology, clinical, bulk chemical, stability, and microbiology testing, manufacturing, product development, marketing, and project management. Additionally, this expert has established quality systems within each of his employers through SOP’s, audits, training, and validation programs, as well as having established quality systems to meet ICH Q10, 21CFR11, 21CFR210/211, 21CFR820, OSHA1910, ISO9000, and ISO13485. His validation programs include master, facility, process, equipment, cleaning, software, hardware, and technology transfer protocols.

Consultant, Kevin Kennedy Associates, Indianapolis, IN
  • Works with clients in preparing and submitting a variety of drug and medical device paperwork.
  • Manages audits and training programs.
  • Establishes regulatory functions for clients.
  • Assists with developing medical devices along with a myriad of other consulting projects.
 
President/ Owner, a laboratory, Bedford, TX
Established consulting company for pharmaceutical, medical device, dietary supplement (nutraceutical), cosmetic, and veterinary product markets within existing analytical laboratory. Business has grown over ten times since purchase
 
Established quality and regulatory compliance for drug, device, cosmetic, food and dietary supplement businesses. Established off site quality unit with FDA approval to handle laboratory testing, quality, and regulatory compliance. Most companies lacked quality systems or understanding of regulatory requirements.
 
Hired and maintained complete laboratory staff to manage day to day chemical and microbiology testing of client products. Hired and maintained complete quality staff to oversee day to day operations at local facilities to represent on site management and oversight of quality.
 
Taught cGMP’s, ISO13485, and cQSR requirements to several clients and presented training monthly to local clients and on-line to overseas and out of state clients.
 
Prepared and successfully submitted 510(K)’s, drug submissions to Australia, drug submissions to Korea, drug submissions to Canada, INDs, NDAs, and ANDAs.
 
Clients include start up biologics, medical device (heart catheter, wound care, external fixation, electric stimulation, spinal cord, breast implant, breast cancer therapy, stent), OTC, sterile fill pharmaceutical, nutraceutical, and cosmetic companies.
 
Partnerships provide entire infrastructure from product development to sales and marketing for small and large sized companies to provide a competitive edge in the marketplace.
 
Director QA, QC, QS, RA, Carrington Laboratories Inc., Irving, TX
Established ISO13485 requirements within 6 months of hire in preparation of audit. Audit resulted in 12 month renewal.
 
Established regulatory compliance for drug, device, cosmetic, biologic, food and dietary supplement businesses. Established regulatory compliance position and strong report with customers.
 
Hired and maintained complete quality staff and achieved high credibility with USFDA and customers. Company suffers from high turnover rates.
 
Taught cGMP’s, ISO13485, cQSR and HACCP to entire organization in preparation of audits.
 
Met all corporate goals for the Quality department in first seven months.
 
Established sterile fill biologic/parenteral facility within 4 months and achieved regulatory approval of drug products within 3 weeks of submission.
 
Managed quality audits by customers, ISO, Texas Department of Health, USDA, and USFDA for positive outcome to company.
 
Developed new product worth $6MM annually for major customer.
 
Quality Engineering Manager, Avail Medical Products Inc., Irving, TX
Established quality function for new Technology and Development Center for international medical device contract manufacturer
 
Established ISO9001/ISO13485/EN46001 requirements within 2 months of hire in preparation of TUV Product Services audit. Audit resulted in 12 month renewal and no non-conformances or observations.
 
Established Management Representative.
 
Completed two successful 510(K) submissions with clearances within 35 days of submission. Managed Quality oversight of product development, assuring compliance.
 
Established filling and packaging business with major pharmaceutical company for $10MM of initial business. Follow-up business was three additional products.
 
Taught quality managers and sales team from plant sites cGMP’s, ISO9000, and cQSR.
 
Met all corporate goals for the Tech Center for entire year of 2002 in first month.
 
Established regulatory function for the corporation and filed letters with the FDA on device listings, establishment registration changes, 510(K) reviews, and submissions.
 
Senior Project Manager/ VP of Marketing, International Isotopes Inc., Denton, TX
Led multi-disciplined, cross-functional teams through successful projects that included compliance, ANDA and Pre-Approval Inspection, Phase III drug and preparation for NDA, computer validation, new medical device and 510(k) submission. Provided input into all FDA submissions. Wrote or revised over 100 SOP’s for compliance. Successful in management of teams (technology transfer and process development) to obtain two FDA manufacturing approvals within a year. Budgeted revenues of $2.5+MM.
 
Established excellent relations with clients after previous adversarial relations through customer driven management practices that fostered personal contact, clear communication, and achievement of goals.
 
Attended and presented at end of Phase II FDA meeting in Washington, DC and pre-construction FDA meeting at the district office.
 
Identified, contacted, and contracted new clients and suppliers for company provided services and projects. Moved company outside radiological niche and into general parenteral fill marketplace to meet business objectives. Assumed role of Marketing Vice President after his departure.
 
Developed new medical device at a cost of $2.25 per unit as compared to the commercial product that cost $34 per unit.
 
Developed multiple radio labeled monoclonal antibody formulas for clients for evaluation toward IND submissions.
 
Quality Director, Mills Biopharmaceuticals Inc., Oklahoma City, OK
Established quality system for start-up medical device manufacturer. Wrote over 120 SOP’s for compliance, Design Control, Validation, Manufacturing Process, Quality Assurance, Quality Control, Specifications, Material Flow, equipment operation, and safety, radiation and laboratory.
 
Management Representative for quality system. Assumed Vice President of Operations roles and responsibilities. Established computer network system, human resource policies and benefits programs, and assisted in establishing Accounting Department.
 
Procured capital equipment and personnel to operate company. Liaison between corporate sponsor and company. Trained corporate sponsor in QSR, customer complaint, and validation.
 
Established manufacturing process, package insert, shipping containers, and DOT requirements for shipping radiological materials. Attended HAZMAT, HAZCOM, and radiation safety training.
 
Led company through successful audits by FDA, State health officials, local inspectors, NRC, and state radiation safety officials. Auditors noted no observations.
 
Assistant Director of Analytical Development, Aronex Pharmaceuticals Inc., The
Woodlands, TX
Prepared company for successful Pre-Approval Inspection by FDA. No observations were noted on 483. Reviewed all compliance documentation in preparation of audit. Revised or wrote 45 SOP’s to establish compliance. Trained personnel in compliance, techniques, and procedures.
 
Initiated Metrology Department to maintain calibration, qualification, and maintenance of over 600 individual laboratory instruments. Validated and initiated metrology software within four weeks of receipt. Established reference standard program.
 
Reduced instrument deviations by 65% by performing routine maintenance and changing instrument parameters to meet specification requirements.
 
Installed and validated client/server laboratory management system software and trained personnel within 21 days, exceeding expectations of a 4 month plan. Became system manager of software program.
 
Established as Chemical Hygiene Officer. Wrote chemical hygiene plan and laboratory safety manual. Submitted annual documents to state.
 
Developed validation plans for the laboratory instrumentation at 50% of the contracted price.
 
Products included liposomal formulations and tissue engineered formulations.
 
Director of Analytical, ILEX Oncology, San Antonio, TX
Established laboratory for start-up contract pharmaceutical development company (CRO) with analytical chemistry, microbiology, stability, formulation, and toxicology laboratories.
 
Procured equipment and personnel to operate laboratories. Established SOP’s, methods, and validation processes with compliance to FDA, ICH, and USP requirements. Supported testing of samples from process development, pre-formulation, formulation, toxicology, manufacturing, stability, and complaints. Developed plans for expansion.
 
Supported 7 key oncology projects in house and 3 key projects with contract facilities continuously. Supported both CRO and internal product projects. Products included solid dose, capsules, sterile fill, oral, implantable, biologic, and parenterals.
 
Developed assays and validation plans for 25% of cost at outside laboratories.
 
Chemistry Laboratory Supervisor/ Manager, Allergan Inc., Waco, TX
Managed 21 staff laboratory operation in team environment to support three-shift manufacturer of medical device and pharmaceutical products. Products were filled on Sterile Fill, Blow-Fill-Seal, Aerosol, Contact lenses, and pharmaceutical gel equipment.
 
Established ISO9000, EN460002, ISO14000, IS301, and Oliver Wright certification and compliance. Established Waco team as the center of excellence within all Allergan facilities for technical and compliance expertise. All new R&D products were processed in Waco prior to transfer to other facilities.
 
Established better relations with Research and Development, Corporate Quality Assurance, Waco Procurement, Marketing, Waco Manufacturing, and the foreign plant sites. Established vendor assurance and reduced raw material testing programs.
 
Developed vendor assurance and qualification plan to save the company about $100,000 per month on raw material testing and warehousing.
 
System manager for laboratory information management system. Developed assays for quaternary amines and organo-mercury compounds. Awarded for mercury waste disposal system that saved the company $65,000 per month in treatment costs.
 
Senior Laboratory Technician, M&M Mars, Waco, TX
Rotated through microbiology, chemistry, and instrumentation laboratories. Performed routine quality and sanitation inspections.
 
Supported Manufacturing and Product Development through increased quality control through statistics and NIR technology. Assisted in development of Peanut Butter, Snickers, and Watermelon-Strawberry Starburst and Skittles.
 
Became instrumentation and microbiology expert in Waco facility. Developed assay procedures and inventory control practices.

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