Kyle Eckhart Email & Phone Number

Thousand Oaks, California, United States

Amgen, Thousand Oaks, California, United States

- Manages quality directives, policies, processes, procedures and metrics in a 21 CFR regulated warehouse for manufacturing of biopharmaceuticals- Manages the operational quality of hired CBPS operations are fully compliant with client service level agreements and standard operating procedures in GMP environment.- Manages the compliance through Productivity reports.- Manage and implement ideas and concepts for corrective action development.- Supports quality source selection and process reviews of suppliers' ability to meet program quality requirements.- Participant in financial productivity and FDA audits

Simi Valley, California, United States

https://www.ammunition1.com/

Thousand Oaks, California, United States

Hands-on work in the executing study protocols, assisting in optimizing upstream (cell culture, scale-up, characterization) and downstream (clarification, chromatography, tangential flow filtration) unit operations for viral vector production  Support technology transfer into vector manufacturing as required  Works closely with external partners on appropriate viral vector process and characterization studies to enable manufacturing  Supports virus analytical method development, qualification, transfer, and associated protocols/reports as needed  Assist with viral vector product quality attribute assessment and scoring to identify critical quality attributes (CQA)  Supports viral vector process and analytical sections for regulatory filings and response to questions

Thousand Oaks, California

Pivotal Process Development- Identify and develop aspects of drug product to advance process design for parenteral drug products.- Design, execute, document primary packages related to drug product design and process development.- Develop solutions to technical problems during process characterization and aseptic manufacturing.- Support clinical and commercial processes into Manufacturing network- Author and review technical protocols, reports, product impact assessments, regulatory sections in support of IND and marketing application submissions-Provide support to clinical and commercial fill/finish manufacturing operations.

Camarillo

Employed May 2, 2018 - May 15, 2019- Perform analytical testing of product related samples: test articles, in process samples, finished products and stability samples- Manages and implement stability programs, analytical method validation/verification, and laboratory studies- Reports all test results and provides notification to Quality Assurance and Manufacturing when excursions are observed- Conducts investigations associated with Out of Specs/Out of Trend test results- Review sample plans and product specifications and verify analytical methods are suited for intended purpose- Performs testing samples associated with Validation activities- Participates in method transfer activities- Maintaining and operating Quality Control Laboratory Equipment- Maintain calibration records and documentation for equipment/systems per procedural requirements- Coordinates external calibration services in support of equipment maintenance procedures- Supports activities associated with Change Control, Non conformance Investigations, CAPA, Work Orders and Planned Deviations

Oxnard, California

Employed March , 2015 - April 27, 2018Summary:Responsible for the creation and implementation of quality improvement and research projects in the clinic, robust statistical analyses of data, and ensures the quality of the database. Performs data entry and extraction on an as-needed basis and undertakes special projects deemed necessary by the Clinic Manager or Medical Director.• Perform research using the CERNER database on clinically relevant topics• Perform quality improvement projects using the CERNER database on clinically relevant topics• Perform robust and accurate data analyses on data used in QI/Research• Create monthly and quarterly reports on the status of projects • Conduct monthly presentations of data as deemed necessary• Directs all QI/Research and Department Meetings, and attends all Clinic Meetings• Staying up to date with new medical literature in the select field of QI/Research.• Assists other departments with their data analyses• Manage the logistics and workflow of the Data Entry Staff• Enters data into the database while ensuring accuracy of entered data• Extracts data from electronic medical records using CERNER while ensuring accuracy of extracted data and follows all HIPAA and JC guidelines related to patient data handling protocols• Consults with SEEDS Data Entry Analyst, Clinic Administrator, Medical Director and Providers to get input about new studies that are suggested for implementation

Oxnard, California

• Management of physical retention samples, including locating retention samples in the carousel or designated shelves, and purging outdated samples. Maintain sample locations in SAP.• Perform physical appearance and visual genetic purity testing in accordance with established policies and procedures.• Perform moisture and seed count testing in accordance with established policies and procedures.• Record results for physical appearance, visual genetic purity, moisture and seed count in SAP.• Divide master samples into subsamples for shipments to various quality labs.• Prepare shipments to quality labs.• Maintain a clean, healthy and safe working environment in compliance with Monsanto Environmental Safety and Health guidelines and housekeeping practices. Attend trainings and wear appropriate PPE.• Perform all duties with a high level of accuracy in order to maintain the integrity of quality results.• Follow established protocols and procedures for testing with consistent attention to detail.Demonstrates full knowledge of seed testing practices, AOSA and ISTA testing guidelines. Responsible for creation and movement of physical samples and for performing designated physical seed quality analysis in accordance with established guidelines.Summary: Responsible for the timely, accurate preparation, evaluation, recording and posting of moisture, seed count, physical appearance tests and management of physical samples.

Malibu, California

Employed October 26, 2013 - June 15, 2014Wedding staff, bar back, runner, and valet

Port Hueneme, Naval Base Ventura County

Employed July 15, 2011 - March 15, 2014 Supervisor: Gerry Legaspi, MBA • Provide swimming lessons to the armed forces and personnel.• Aid in surfing clinics and other NBVC events.

Master Of Science - Ms, Biotechnlogy And Bioinformatics, Gpa: 3.839

Activities and Societies: Emphasis in Biomedical EngineeringP.I. Bill Tawil, PhD, M.Sc, MBA • The effect of cannabidiol-infused collagen.

Bachelors Of Science, Biology, General

Activities and Societies: Undergraduate Student Research, January 2011-May 2011 P.I. Chad Barber, PhD - General consensus and public.

Hs Diploma, Gpa: 3.4

Activities and Societies: Varsity Captain of the Water Polo and Swim Team, 2007-2009 Oxnard High School Record: 50 Yard Freestyle 3rd.