Kate Evans Email & Phone Number

Boulder, Co, Us

Colorado, United States

Kate Evans, Ph.D. is the principal and owner of Longboard Scientific Consulting Corporation based out of Colorado. Recent projects include cGMP audits, cGMP analytical RD testing (pharmaceuticals), Equipment Qualification (IQOQPQ), cGMP manufacturing and DMF submission support and introducing testing guidance within regulatory framework for state programs. She also supports existing testing laboratories with sample preparation, methods development and validation, training of staff, and ISO 17025 implementation; she also performs assessments for both ANAB and A2LA.

Ogden, Utah, United States

Contracted with Carlton National Engineering Support expansion of R&D testing laboratory in company-wide cGMP initiative. Wrote and executed several instrumentation qualifications (IOQ), wrote and execute Nitrosamine assay for FDA submission including 6 matrices by LC-QQQ. Develop, wrote methods for TOC USP 643 and conductivity USP 645. Trained on LC QTOF, GC-QTOF, GCMSMS and ICPMS. Began development of extractable/leachable testing- method optimization by LC-QTOF (Agilent). Provide ongoing analytical testing support as assigned.

Dallas-Fort Worth Metroplex

Reviewed and provided reports/corrective action and risk assessment to support large scale audit

Miami, Florida, United States

Review all COA’s daily, pesticide data reports, environmental assessments, water quality studies and determine risk to over $10 million in plant crop.Implemented global ordering and inventory management process, including purchase order procedure with accounting to track laboratory expenses worldwide.Instituted global equipment maintenance plan for laboratory instruments and extraction equipment, increasing overall uptime and reduction in onsite repairsDeveloped and delivered an in-house training program for over 10 staff scientists, technicians and engineers.Demonstration equipment installed/evaluated: Ball mills, homogenizers, grinders, XRF, Water activity.Accomplishments:Saved millions in potential lawsuit(s) by implementing, overseeing and reviewing extractable/leachables testing with Jordi Labs before launch of new Vapor Cartridge product release.First fully validated method (Potency) submitted to Texas DPS to improve overall data quality and product release testing of CBD product line.Implemented shelf life and stability testing plan, entire inventory (FL, TX) re-analyzed, product wasted, combined and retested on set schedule enhancing consumer safety.

Durango, Colorado, United States

Hands on Laboratory Director and manager of a staff of 3 - responsible for all aspects of laboratory operations from sample intake to release of final results - Qc (control charts) and quality systems to meet both CDPHE and ISO 17025 requirements. Oversee Hplc potency - terpenes - residual solvents and microbial analysis,optimize and re-validated methods as required.

Greater San Diego Area

Establish presence in growing industry including testing laboratory space and process manufacturing/extraction. Provide up to date research and information regarding regulations, methods and connections to industry leaders. Performed cost of analysis to establish capital investment long and short term projections, predicted margins and overhead (labor, facilities and equipment). Active member of the following committees that are in process of forming standards and guidance documents in the space: ASTM D37 Committee member (Laboratory, Processes, Security and Transportation, Quality- QMS fundamentals, AOAC SPSFAM Working Group- Potency Methods of Analysis/Validation, Participation of Pesticide Round Robin Laboratory testing to gauge current method performance (LCMSMS, GCMSMS).

Kailua Kona Hawaii

Develop,validate, and perform day to day routine sample analysis specializing in toxicology confirmation. Expand drug testing service to include locally owned clinics and substance abuse centers. Offer customized service including courier service, custom panels and reporting.Added Hamilton robotics system to fully automate workflow and expand sample volume including specialized SPE (DPX) sample preparation. Hawaii Licensed CLS specializing in Chemistry.

Kailua Kona Hawaii

• Participate and Lead Management of Change activities in support of process improvement and HSSE/Safety, implemented CO2 monitoring system in grow rooms including purchase and installation of detectors and alarm system.• Started Microbiology testing program (3m Petrifilm) for QC and CofA development of biomass.• Installed new gas generator systems with clean delivery including Hydrogen and Nitrogen systems.• Implemented calibration and service renewal plan, significantly reducing service contract costs and maintenance of analytical systems (Millipore, Agilent, Beckman, Hach and Consteril)• Team lead for SFC CO2 Extraction technology evaluation• Develop new methods in the area of bio-algae/ biomass for LCMS (Avanti Polar Lipids- CRO), HPLC, GC, GCMS and validate existing methods. Implemented QC charting (SQC’s) and QC controls for calibration.• Analytical lead for ATP3 harmonization R&D project ($15 million)- including analytical support- FAMES and TAG analysis by Agilent GCMS and HPLC/CAD. (AOAC methods)• Provide technical expertise for updating and maintaining onsite waste water permits including environmental monitoring and assist in support of analytical tests/measurements.• Streamline Inventory management system, develop new forms and tracking systems• Develop and implement stability program and long term shelf life studies of dried biomass• SOP preparation, maintenance of documents as per GMP. Review, Change and Distribution of Standard Operating Procedures (SOP’s), Specifications and Quality Formats.• Retrofit and upgrade all laboratory facilities and services including gas lines, water systems and instrumentation line power (UPS).

Western Us

Support Chromatography Consumable sales, manage team of 5 remotely located people in US. Applications development in clinical, pharmaceutical, nutraceutical and other vertical markets. • Activities include customer technical support, pre and post sales application support and methods development (LCMSMS, GC and SPE-extraction methods), conference attendance, public speaking- seminar delivery at key accounts and technical training, demonstrations.• Successful Development and support of applications- sample preparation and LCMSMS methods of the following - Vitamin D, Testosterone, small molecule lead drugs, dyes/cosmetics, food/beverages (including hops analysis, cannabis), and nutraceuticals (protein powders/drinks)• Developed and supported (Turboflow) complex drug assays (pain management, street drugs, drugs of abuse) at key Clinical Accounts- including Quest and Ameritox.• Implemented a process (PPI) to streamline all customer product quality complaints and sales support activities using automated software (Salesforce.com) tools.• Obtained DEA (CA&PA) licensing and Environmental Permits. 100% Successful inspections.• Manage Laboratory Facility: Successfully added new laboratory in Western Region (including build out of existing facility) to house LCMSMS

San Diego, Ca

Innovative Pharmaceuticals was successfully acquired by (May 2011) Amneal Pharmaceuticals, a Transdermal Division has been created with small pilot batch manufacturing and R/D in San Diego CA with ramp up of manufacturing for pain patch in various formats, reservoir and matrix in NJ. Amneal Pharmaceuticals, L.L.C., a pharmaceutical company, engages in developing, manufacturing, and distributing over-the-counter and generic prescription medicines. Its products include acetaminophen caplets and tabs, analgesic tabs, aspirin tabs, chlorpheniramine maleate tabs, diphenhydramine caplets and capsules, docusate calcium soft gels, ferrous sulfate tabs, ibuprofen tabs, multivitamins, vitamin B complex with C capsules, vitamin E soft gels, vitamin C tabs, colchicine tabs, folic acid tabs, metronidazole tabs, naproxen tabs, prenatal plus tabs, and sucralfate tabs. The company was founded in 2001 and is based in Paterson, New JerseSmall generic pharmaceutical startup specializing in pain medication and transdermal drug delivery technology. cGMP manufacturing and testing specializing in controlled substances and generic medications. DEA/FDA regulatory experience, SOP and standard methods, process validation, methods validation and assay development, stability/dissolution. Hands on operation of specialized coating equipment and heat sealing/packaging equipment. Filed Patent: INPHAR.007PR PATENTTRANSDERMAL RESERVOIR PATCH, listed as inventor. Contract packaging -Rohrer equipment and Mathis Coater- coating capability. Operate and maintain manufacturing equipment and clean room environment.

Methods development and technology transfer and optimization of transdermal technologies including fentanyl and lidoderm patches.

San Diego, California, United States

PreClinical Metabolism Scientist- studied candidate drug 56418 now approved treatment for endometriosis, principal operator of Waters UPHLC-QTOF Metabolynx and Markerlynx.

Los Angeles Metropolitan Area

Double digit growth in the following (insurance premiums) renewable energy sector- BioFuels, BioDiesel and Recycling (chemical), chemical transport by rail and cosmetics. Instituted multi-million-dollar savings by instituting safety initiative at several recycling centers in Los Angeles reducing injuries and losses. (Sims Hugo Nue).

Orange County, California, United States

Waters Corporation -Technical Support Specialist, LA region.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, continue year upon year growth.

Doctor Of Philosophy - Phd, Analytical Chemistry, 3.99 Gpa

Activities and Societies: Ohio Board of Reagents Scholarship Recipient 1994.Analytical Chemistry (Chromatography) Specializing in polymer.

Certification, Occupational Health And Safety

Validation Certificate, Biotechnology/Validation

Materials Science Internship

ESCA, Auger and Electron Microscopy-SEM funded by Smithsonian Institute for Art Preservation and Conversation- study surfaces, resizing.

Bachelor Of Arts - Ba, Chemistry

Activities and Societies: Varsity Lacrosse - 3 yearsBA degree with major in Chemistry, minor Fine Arts.