Consultant, Kevin Kennedy Associates Inc.
Providing expertise in executive management related to microbiology, biochemistry, quality (cGMP), R&D, and related expertise to a wide variety of clients.
Assistant Vice President, Vaccine Development, Wyeth Research and Development
Provided scientific leadership for the development of manufacturing processes for new vaccine candidates. Role included planning and ensuring timely execution of process development and clinical supply production for new products in accordance with cGMPs and company R & D goals. Assigned and allocated resources (personnel, capitol, and equipment) to meet project timelines. Functioned as technical leader for multiple vaccine projects. Led project team that produced Phase 3 conjugate vaccines at Pilot and full-scale facilities. Assisted with tech transfer to commercial sites and with process validation efforts and strategies. Led process development efforts for new protein antigens expressed in E. coli. Directly involved with CM&C sections for new vaccine submissions. Technical lead for outsourcing projects, evaluating technical competence for protein antigen or plasmid DNA production. Assisted with commercial strategy for Phase III manufacturing, including tech transfer, technical management of CMO and assisting with commercial manufacturing agreement. Served on specification committee, Confirm team (Phase 3 Team) and Global Technology Teams for two of Wyeth's most significant vaccine candidates (Prevenar13 and Meningococcal B vaccines). Six Director level reports. Department size of approximately 90.
Vice President, Technology, Cambrex Bio Science, Inc (Currently Lonza)
Formed a Process Development Group within a manufacturing environment to increase corporate capabilities and revenues. Promoted the PD business plan by establishing operational model, facility build out requirements, staffing, budget and equipment requirements and establishing client portfolio. Championed and presented strategic plan to Corporate resulting in $5M facility build out. Staffed group, developed integrated team approach, resulting in 29% of the site revenues for 2003. Responsible for developing strategic plan for cell culture integration and establishing this group as an independent business unit. Managed technology program responsible for process improvements including fermentation, upstream and downstream recovery, purification technologies, initiation of cGMP documentation (Material Specifications, SOPs, Production Records, Process Flow Diagrams), specifying scale-up parameters from 10L to 1000L processes. Responsible for technology assessment of enabling expression technologies for in-licensing opportunities to distinguish the Business unit from competitors. Directed projects requiring new genetic constructs, fed-batch fermentations of E. coli, Gram-negative/positive microorganisms and yeast, development of clarification methodologies, inclusion bodies refolding, novel technology for scale-up and purification of plasmid DNA that exceeds gene therapy requirements with respect to plasmid quality, impurities and endotoxin levels. Functioned as Project Manager and technical leader for major pharmaceutical and Biotechnology clients, and for process development clients. Establish project scopes, schedules, and communication guidelines, and directed technical aspects of projects. Demonstrated leadership and communication skills resulted in successful cGMP production and timely delivery of bulk Active Pharmaceutical Ingredient. Developed strategies for technology transfer for external and internal projects. Developed corporate technology transfer guidelines, incorporated Project Managers as group leaders for successful transfer of client technology through the cGMP system. Assisted with formulating corporate sales strategies, technology marketing and establishing a client portfolio for the corporation. Responsible for assessing client technologies, generating project proposals/statements of work and pricing for technical improvements, scale-up studies and cGMP campaigns. Co-authored government grants with clients. Received President's Quality Award. Four direct reports, staff of 30.
Staff Scientist, W. R. Grace and Co., Columbia, MD
Senior Research Microbiologist, W. R. Grace and Co.
Research Manager/Principal Research Scientist, Genex Corp., Gaithersburg, MD
Senior Research Scientist, Genex Corp.
Postdoctoral Research Fellow (NIH) and Instructor of Microbiology, Medical College of Virginia, Richmond, VA
Postdoctoral Research Trainee, (NIH) Cellular and Developmental Biology, Yale University, New Haven, CT
