Manager Medical

KATHERINE EVANS, PH.D.

**** ***** ******** ****** ******** Springs, CO 80907 C: 970-***-**** *********@*****.***

Executive Summary

Results driven scientific professional - with solid experience in Analytical Methods Development/Validation/Transfer, Research and Development, Laboratory Management/Design and Operations Workflow. Excellent problem solving ability with the capability to work successfully in fast paced environments. Offering sharp writing and interpersonal skills with exceptional technical knowledge to meet customer demands and project deadlines.

Skills

Data analytics (integrating SW/HW and LIMS)

Regulatory - FDA, cGMP, ISO and DEA

Methods Development and Validation (IQOQPQ)

Strong presentation skills

Integrate automation and software (E-Notebooks, Atlas GxP)

Training program implementation

Excellent ability to handle onsite regulatory audits

Chromatography Instrumentation Specialist

Laboratory Build-out (facility) design and Workflows

Quality Management

Technical Writing/SOP Development

Experience

VP of Laboratory Operations, Global- Colorado based

Knox Medical/Fluent Cannabis Care 11/2018- present

Oversee and lead global QA laboratory program for a Florida based medical cannabis producer. Evaluate all operational processes and procedures, and develop strategies with implementation plans to improve and standardize all aspects of operations at a global level - including laboratory testing methods. Designed key strategies to enhance and streamline overall operations including vendor management and ordering system for all sites- saving on overall cost of consumables and analysis costs. Wrote and maintained documentation SOPS, methods validation reports, work instructions of operation plans. Hire employees, mentor and advise, promote employees, assign and evaluate work. Continually assess and develop operating procedures and processes to achieve maximum efficiencies for the business utilizing and directing process excellence methodology and resources; defines and leads process improvements to reduce costs and improve efficiency providing for current and future needs (CO2 Extraction, oil processing and formulations).

Laboratory Director 03/2018 to 09/2018

Green Labs Solutions Durango, CO

Oversaw entire laboratory operation (cannabis testing) including 4 personnel, set all testing schedules and improved workflow and quality systems to meet regulatory requirements (ISO 17025).

Testing includes sample homogeneity, extraction, sample preparation/dilution, microbial (bacteria, yeast and mold), residuals solvents GC-HS, Potency-9 Cannabinoids by HPLC-UV and Terpenes - GC-FID.

R&D Director 06/2017 to 03/2018

Patriot Environmental Services, Inc. San Diego, CA

Delivered extensive cost analysis and developed business plan to expand current environmental (asbestos, mold and lead) testing business into cannabis space.

Actively maintained up-to-date knowledge of applicable state and Federal laws and regulations.

Analyzed facility activities (LIMS and instrument service providers) and data to properly assess risk management and improve services.

Contractor- Quality Manager 03/2016 to 05/2017

StemGenex Stem Cell Research Centre San Diego, CA

Reviewed specifications for products, Evaluated FDA gap analysis from onsite audit for aseptic processing and suggested improvements- i.e. biosafety cabinets, room clearance, personnel training, validation and calibration plan for all processing equipment. Arrange vendor visits for HVAC/HEPA ventilation improvement, wrote summary plan.

Determined project schedules and maintained timeline with proactive adjustments to workflow.

Collaborated with support personnel to affect satisfactory and timely solutions including implementation of clean room procedures and changes to cell processing steps.

Implemented barcoding of products meeting ISBT 128-AABB labeling standards.

Completed all SOPs, Quality Manual and executed validations in order to file AABB application 01/2017.

Laboratory Operations Manager 02/2014 to 03/2016

S&G Labs Hawaii Kailua-Kona, HI

Scheduled, oversaw and trained staff to maximize productivity. Including urine collection, intake and aliquoting for immunoassay screening on Siemens Viva-E platform.

Established and managed quality control program covering all laboratory activities. Successfully passed 99% CLIA/COLA inspections moderate and high complexity (LCMSMS)

Maintained compliance with all laboratory, company and legal regulations. (CLIA)

Oversaw documentation and reporting requirements with an accurate and efficient mindset through use of web portal. Implemented new LIMS, sample preparation processed and automation (Hamilton Robotics) to increase throughput and accuracy of results.

Quality Manager/Analytical Chemist 03/2013 to 02/2014

Cellana-Algae Research Kailua-Kona, HI

Carefully selected, developed and retained qualified staff, as well as trained 3 new staff to meet government grant objectives, ATP3 harmonization project.

Established laboratory annual budget and conducted monthly reviews to ensure finances were being properly allocated- including laboratory consumables, service contracts and calibration services.

Performed lab tests- GC, GCMS and communicated results to meet project deadlines and objectives. Optimization of sample preparation and derivatization for fatty acid determination. (FAMEs)

Applications Manager 06/2010 to 02/2013

Thermo Fisher Scientific (Consumable and Mass Spectrometry Division) San Diego, CA

Provided hands-on technical support, advice and mentoring to a team of highly skilled professionals, six total direct reports, to meet sales and financial objectives in North America.

Maintained open and effective communications with customers in order to grow business at specific key accounts- including Quest Diagnostics, Ameritox and Gilead Sciences.

Provided onsite training, hands on with products and method development to customers including hardware and software troubleshooting of sample preparation techniques, column chemistry selection and LCMSMS instrument optimization.

QC Director- Manufacturing and Testing 08/2008 to 06/2011

Innovative Pharmaceuticals (Generic) San Diego, CA

Developed and executed all validation documentation and process control for specialty coating & packaging equipment as well as facility design and build-out changes.

Investigated equipment failures, identified there cause and initiated methods to resolve such issues.

Inspected, calibrated and tested the procedures and instruments that were utilized to create and manufacture transdermal products.

Ensured that the entire validation process was documented and included all changes that took place. Created Master Validation Plan and HVAC facility validation plan.

Company sold - assisted with methods transfer and decommissioning CA manufacturing and testing site to New Jersey, 6-8 month process.

Preclinical QToF Operator- Metabolism 02/2007 to 03/2008

Neurocrine Biosciences Inc. San Diego, CA

Optimized and developed MS/MS data collection QToF- UPLC Acquity/MS/MS for better accurate mass measurements and confidence in metabolite profiles.

Successful Chiral separation (56418) method developed,

Organized and implemented (GLP) data storage for easy access and retrieval of all LC/MS/MS data for FDA report submission. Indiplon not FDA approved company wide layoff.

Risk Manager (Environmental) 03/2006 to 03/2007

AIG Los Angeles, CA

Provided risk management and assessment surveys for national and medium-sized accounts related to the Chemical, Food and Beverage, Biodiesel, Medical Device and Cosmetic industries by performing telephone audits and onsite inspections.

Resolved issues quickly through meticulous research and quick decision making, interacting with underwriting team to make quick policy decisions.

Technical Support Specialist 02/2002 to 03/2006

Waters Corporation Irvine, CA

Provided thorough support and problem resolution for customers through onsite training and methods development (HPLC, UPLC, SFC and high throughput purification) using extensive product line including sample preparation and column chemistry. 100% success rate of customer demonstrations of instrumentation, both hardware and software. LA Region #1 Sales Region 2004.

Developed and maintained technical expertise in semi-preparative and preparative chromatography in support of medicinal chemistry library screening.

Developed documentation for common processes for both technical support group and end-users, including detector systems and automated methods development.

Further developed Open Access software tools. Increased sample purification throughput and accuracy in reporting, data storage by implementation of OATools.

Academic Background

Ph.D. Analytical Chemistry- Specializing in Polymer Solubility

University of Akron Akron, OH

Magna cum laude graduate. Ohio Board of Reagents Fellow.

Bachelor of Arts: Chemistry

Goucher College Towson, MD

Undergraduate Internship- Johns Hopkins Material Science Department.

Activities and Honors

AOAC Cannabis Working Group Member 2017-present. Participation in development of Pesticide Standard method: Participate in 2018 Pesticide Round Robin Laboratory testing to gauge current method performance (LCMSMS, GCMSMS) and further develop testing standards.

ASTM D37 Cannabis Standards Development- Laboratory Validation and Controls, Processes, Quality (QMS top down approach-Facilities and Equipment, Process Validation & Verification, Training and Certification and Safety/Security.

ASCP- Chemistry Technologist 2015- present. Hawaii CLS License: #5361.

ABSCIEX Training (2019) Cannabis Pesticide training (3 day course) hands on with LCMSMS 5500/6500+

Websites

www.longboardscientific.com

https://www.linkedin.com/in/drk8evans/

Consulting Projects

Bral Realty Advisors- John Bral Owner. Design laboratory (Irvine CA), provide workflow and safety documentation.

Biofore, Greg Coons- CEO. Draft SOPS for submission to the BCC (CA)- Pesticides and Heavy Metals for mobile lab project.

Knox Medical (Winter Garden FL) Gap Assessment on internal QA laboratory. Validation of HPLC potency method full preventive maintenance on equipment *(purchased from 3rd party), provide Methods Validation Final Report.

Bel Costa Laboratories (Long Beach, CA) Gap Assessment - workflow, pesticides and sample preparation

Biopharmaceutical Research (DEA schedule 1 manufacturing and testing facility),

Thermo Fisher Channel Partner (Preferred Vendor for Clinical and Translation Research)

UDL, Van Nuys CA. Verify installation of Transcend multiplexing system (LCMSMS) for 77 compound drug panel, calibrate, develop method and train personnel on Tracefinder software. Company Sold.

Amneal Pharmaceuticals Methods Transfer and Decommissioning Manufacturing Consultant-transdermal project.

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