Consultant, Kevin Kennedy Associates Inc.
Providing expertise in process validation and compliance, biotechnology, fermentation, cell culture, purification, plasma fractionation and recovery, viral risk management, cGMP, and related expertise to a wide variety of clients.
Senior Project Manager, validation and compliance consulting firm
Managed and oversaw a validation and compliance consulting firm serving the regulated industry in the areas of pharmaceuticals, biologics, cosmetics, devices, food, and diagnostics. Provided consulting and contract services to leading biotechnology companies Amgen - Thousand Oaks, CA Rhode Island, Puerto Rico Operations and Biogen-Idec - Oceanside CA, covering process validation of fermentation, purification, membrane filtration processes and cleaning procedures.
Manager, Validation, Bayer, Berkeley, CA
Managed and oversaw validation function for the purification department (projects, personnel, contractors/consultants and fiscal management). Developed and managed the change control program. Developed, wrote and reviewed corporate, group and divisional directives, policies and standard procedures. The responsibilities covered both plasma and biotechnology derived products. Program responsibilities also included managing all scientific, technical and administrative functions including the science, staffing, personnel, planning, operations, and program management. Form FDA 483 and Warning Letter responses and general cGMP validation, training.
Manager, Process Validation, Alpha Therapeutic Corporation, Los Angeles, CA
Developed an entirely new function, process validation within six months. Successfully completed process validation for all commercial product lines within 18 months. Created a new data bank for process validation and developed a statistical process control program. These projects involved coordinating the functions of ten departments and an external contract firm on a consulting basis. Managed the process validation function and projects including program development, project planning, project execution and documentation in an interdisciplinary environment. Program responsibilities also included managing all scientific, technical and administrative functions including the science, staffing, personnel, planning, operations, and program management. Form FDA 483 and Warning Letter responses and general cGMP validation, training.
Vice President, Pre-Clinical Development, Penton, Monrovia CA
A start-up drug development company.
Manager, Quality Control, Manager, Virology Department, Supervisor, Virology Department, Senior Scientist, Virology Department, Baxter International, Hyland Division, Immunotherapy Division, Gene Therapy Division, Deerfield, IL
Managed all scientific, technical, budgets, projects, resources, and programs. Managed the viral risk validations program according to USA, EEC regulatory guidelines to support the licensure of blood-derived and cell culture-derived products. Advisory to the regulatory, marketing, clinical and manufacturing departments and the American Red Cross regarding virology issues. Initiated and developed gene therapy delivery systems involving viral vectors. Initiated and developed an anti-viral gene therapy program involving molecular chimeras to disrupt the HIV replication cycle and to destroy infected cells. Responsible for the development and the general organization of a QC department including functions, organization, administration and managing the operations within the newly formed Biotech Group, Gene Therapy Division.
Senior Scientist, Children's Hospital, St. Paul, MN
Conducted scientific research on herpes simplex viruses (types 1&2), cytomegaloviruses, varicella-zoster virus, and adenoviruses. Obtained NIH funding as part of a Program Project for work on CMV. Managed the science, budgets, staffing, personnel, planning, grants and projects.
Research Fellow, Molecular Genetics, Minnetonka, MN
Conducted scientific research on the chemistry and function of monoclonal antibodies expressed in E. coli.
Associate Scientist, Children's Hospital Of Philadelphia & Wistar Institute, Philadelphia, PA
Conducted scientific research on Reye's Syndrome and the pathogenicity of influenza viruses.
Research Assistant, Teaching Assistant, University Of Minnesota, MN
Conducted scientific research on the induction of immune function by influenza viruses and immunologic polypeptides of the hemagglutinin. Obtained a meritorious dissertation grant from the University of Minnesota Graduate School. Taught various biology classes.
