Katherine Wilson

619-***-**** ady0pi@r.postjobfree.com

Qualifications and Skills

•Over 20 years work experience in the biotechnology industry

•Experience in Analytical techniques using HPLC & µHPLC (reverse phase, normal phase, Titer, IEX, CIEX, SEC, AAA, protein A purification), LC/MS, NMR, ICP, SDS-Page, gel chip, small scale protein purification, ELISA, FTIR, TOC, TLC and Karl Fischer

•Worked with cell lines ie: CHO cells that produced the antibodies, raising titers from 50% to 93%

•Experience with Stability studies and protein formulation development, GMP and GLP

•Method optimization, development, validation and transfer

•Proficient with various laboratory equipment such as Agilent HPLC 1100 & 1200, Dionex HPLC, Waters Alliance HPLC and µPLC, Thermo µPLC, Veloce (Nanostream) HPLC, Perkin Elmer Spectrometer Optima 2100DV, Bruker 500 NMR, Agilent bioanalyzer, PerkinElmer UV/Vis Spectrometer, Igen M8 ECL Detection System, Zwick Force Testing machine, Molecular Devices Threshold - computer software such as Chemstore, Chemstation, Chromeleon, MassHunter, Empower II, 24 Karat, Winlab 32, Topspin 1.3, Nugenesis, UV WinLab, Windows, Outlook, MS Office (Excel & PowerPoint).

•Strong organizational and communication skills, whether mentoring or giving a presentation

•A motivated critical thinker accustomed to working independently as well as with team members

Work Experience

Oct 19 – Oct 22 Avexis Pharmaceuticals San Diego, CA

Sr. Analyst Quality Control

Perform cell based potency and impurity assays, of in process, release and Stability samples under GMP conditions

Investigations to determine root cause of deviations and non-conforming results, identify and implement CAPA’s

Assay troubleshooting, qualification and validation.

Revision and writing of SOP’s

Nov 18 – April 19 Trilink Biotechnologies (contract) San Diego, CA

Quality Control Chemist II

Perform testing, analysis and reporting of raw materials, finished product and Stability samples using HPLC, µHPLC and LC/MS

Development, qualification, verification, transfer and validation of methods for the µHPLC

Troubleshooting, and calibration as well as daily and weekly maintenance of the lab equipment

Normal lab duties ie: ordering supplies and buffers, maintaining logs, implementing 5S

Dec 17 – Nov 18 PolyPeptide Group (contract) San Diego, CA

Quality Control Analytical Chemist II

Perform testing, analysis and reporting of raw materials, API, Stability

Development, qualification, verification, transfer and validation of methods via HPLC

Training of other analysts on Instruments and methods

Initiate and complete OOS, OOT, Deviation reports, RMS, DSS, Change Control and response to audit finding CAPA’s

Troubleshooting, maintenance and calibration of the analytical equipment

Create, review and revise current Protocols

Nov 12 – Oct 15 Glanbia Nutritionals Carlsbad, CA

Quality Control Laboratory Analyst II

Extensive experience in Develop/Optimize and validating quantitative HPLC analytical methods and bringing in house, significantly reducing time and money on outsourced testing

Analytical testing of nutritional raw materials and finished formulations (ie. calcium pantothenate, (vitamin C) fat soluble vitamins (Vit A’s, D’s, E’s, K), water soluble vitamins (B5, B12, biotin, folic acid) via HPLC and µHPLC

Troubleshooting, maintenance and calibration of the analytical equipment

Review and revise current SOP’s and write new SOP’s as I developed the methods, then trained co-workers on those assays

Data review and reporting and conduct investigations of suspect results

Dec 09 – May 12 Verenium Corporation (contract) San Diego, CA

Sr. Research Associate I, Product Technical Support Group

Lead personnel for all HPLC analytical testing, maintenance, data analysis and reporting

Testing for mono, di & triglycerides and fatty acids via HPLC

Testing for Calcium, Magnesium, Phosphorus and Iron in Oils via ICP

Testing for Phospholipids & their enzymatic products via NMR

April 08 – January 09 Amylin Pharmaceuticals (contract) San Diego, CA

Research Associate II, Product Development

active member of a team focused on improving the patient’s experience with our products

Developing and implementing studies to answer questions and make recommendations regarding off-label indications for a marketed drug

Executed ISO methods and completed studies on: container closure, compatibility, and clinical administration

Zwick Force Testing

Method transfer of HPLC methods

Presented experiments and data and answered questions at the department level

Wrote RESPL, REST and guideline documents

Feb 02 - March 07 Biogen Idec Corporation San Diego, CA

Associate Scientist II, Analytical Development

•Routine testing in support of process development for Purification Development, Cell Culture Process Development, Manufacturing Sciences and Formulation. List of Assays to include: Amino Acid Analysis, DNA quantification, Titer, SEC, IEX, CIEX, Protein A Purification, HCP, UV spectrophotometry, ELISA, Gel Electrophoresis, SDS Page, Gel Chip, PCR

•Optimized a method for the Identification and quantification of Amino Acids by automating the assay. More than doubled throughput and halved prep time of samples.

•Conducted method qualifications and transfers from Quality Control and Analytical Development East

•Tested and Implemented new products, protocols and equipment to increase laboratory efficiency and data quality

•Draft and implement new Standard and Equipment Operating Procedures for the Analytical Development Laboratory

•Troubleshooting, maintenance and repair of Agilent HPLC’s

•Provide quality data in a timely manner. Maintained control charts.

Presentation of unique research to entire department (east and west coast), assisted in the community lab to present science to jr. high school students, wrote a presentation and spoke to high school students in Oceanside.

•Interviewed applicants, trained laboratory personnel, maintained laboratory supplies, ordered new laboratory equipment, involved with all aspects of the growth and organization of our lab.

Sept 1999 - Oct 2001 Scripps Institute of Oceanography La Jolla, CA

Research Intern and Expedition Volunteer

•Administrative laboratory duties, ordering supplies, maintaining chemical log, maintain database, journal searching and acquisition. Basic lab duties i.e. Autoclaving, dish washing, sterile techniques, streaking, staining and counting bacteria isolates.

•Dyed, sieved, identified, stored, biomassed and compiled data for macrofaunal communities of an oxygen minimum zone off the Peru-Chili margin. Wrote and presented data at a research conference

•Participated in a two-week expedition aboard the Thomas G Thompson, using the Remote operations vehicle JASON. Sorted, sieved and preserved specimens. Obtained, identified and cataloged organisms. Kept JASON dive logs

•Separation, isolation purification of anti-cancer compound, Bryostatin, from Nudibranchs and Bryozoans. Wrote and presented the data at a research conference March 2001.

Education

1999-2001 University of California, San Diego La Jolla, CA

B.S., Biochemistry and Cell Biology

1996-1999 Southwestern College, Chula Vista Chula Vista, CA

A.S. (Biology), June 1999 and A.A. (General Studies), June 1998

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