Kathryn Kennedy

Senior Manufacturing Inspection Readiness Lead @BioMarin Pharmaceutical Inc.

Daly City, CA, US
MOBILE NUMBERS
+14•••••••21

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WORK HISTORY

Jun 2025 — Present

Senior Manufacturing Inspection Readiness Lead @BioMarin Pharmaceutical Inc.

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Novato, CA, US

EDUCATION

2006 — 2008

California State University-Sacramento

Bachelor's Degree, Biological Sciences, Clinical Laboratory Technology

SKILLS

Integrity TestingValidationTrackwiseDmsCapaPomsCipManufacturingSds PageWestern BlotLimsSapBiotechnologyProtein PurificationLife SciencesGas ChromatographyBiopharmaceuticalsTechnology TransferCell CultureSouthern BlotPi: Plant InformationPcrMcsFreeze/Thaw SkidsIon Exchange ChromatographyProcess MonitoringTotal Plant BatchP&Id VerificationPomsnetSipGmpHplcTech TransferCertified TrainerProtein a ChromatographyCell Based AssaysAseptic TechniqueElisaViral FiltrationExperion

ABOUT KATHRYN KENNEDY

Leadership in cross-functional projects has marked my tenure at Biomarin, especially in implementing change controls, creating and executing corrective and preventive actions (CAPAs), and advocating for continuous process improvements. My role as a Senior Investigations Specialist is defined by leading complex investigations, facilitating root cause assessments, assessing final impact, and presenting to the Material Review Board and auditors where applicable. With technical proficiency in tools like Veeva, Visio, PI, LIMS, P & IDs, Unicorn, Batch View, DCS, and MCS, familiarity with Minitab, Oracle EBS, and SAP, I\'ve led Quality Risk Assessment discussions and have been instrumental in implementing process improvements. The organization relies on my expertise to coordinate with departments such as Automation, Validation, Engineering, and Supply Chain, ensuring comprehensive contributions to project success and process optimization.I\'m open to entertaining challenging leadership opportunities offering growth and development potential within the strategic process implementation, operational excellence, and quality investigations space.

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