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Development Safety Officer

Location:
San Diego, CA, 92117
Posted:
September 01, 2012

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Resume:

John Stankowski

**** ****** *****, **** #***

San Diego, CA 92117

(Home) 858-***-****, (Cell) 858-***-**** oav4an@r.postjobfree.com

PROFESSIONAL PROFILE

Accomplished analytical chemist with proven history of success in biotechnology, chemical, pharmaceutical, and food additives research industries. Skilled in methods development and validation, analyses of drug substances and drug products. Possesses hands-on experience in analytical research studies contributing to applications for target proteins, small molecules, and bioproduction end products. Adept at maintaining and troubleshooting analytical instruments and excelling in a fast-paced team environment.

CORE COMPETENCIES

Advanced Analytical Method Development - Experimental Design - Data Presentation

Laboratory Management - Six Sigma Green Belt - Research Planning - Applied Research & Production

NMR - HPLC (UV,CAD, FL, MS) - GC (FID,FTIR,MS) - UV - IR - LC/MS/MS (Agilent & ThermoFisher)- TOC

WORK EXPERIENCE

Synthetic Genomics, Inc., San Diego, CA 2011-2012

SENIOR RESEARCH ASSOCIATE-ANALYTICAL CHEMISTRY

Responsible for developing and optimizing analytical methods for the quantification of lipid classes, proteins, amino acids, organic acids, and carbohydrates from bioproduction. Also used NMR to discern purity of vitamin conjugates. Data presentation and report analysis was performed across multi-functional team environments.

• Utilized Dionex Ultimate 3000 LC (UHPLC) and fluorescence detection of pre-column derivatives for high throughput screening of amino acids produced by thraustochytrid and yeast fermentation for classification of organisms as a viable food product. Enabled a 2x increased sample flow for amino acids analysis.

Biogen Idec, San Diego, CA 2010-2011

ASSOCIATE SCIENTIST III

Designed and performed stability studies on high concentration protein pharmaceutics. Performed analytical method development and laboratory support including maintenance of HPLC (UV and PDA), UV and IR instruments. Data presentation and report analysis performed for this application.

• Utilized analytical chemistry expertise to rewrite SOPs for method applications and GLPs for laboratory tasks resulting in improved workflow and efficient application regarding protein formulations.

INDEPENDENT CONSULTANT, San Diego, CA 2007 - 2010

Leveraged research experience and technical skills to organize laboratory space and install instrumentation for independent biotechnology laboratories in the San Diego area.

• Ensured laboratory set-up in compliance with California environmental health and safety regulations and existing company protocols.

• Utilized analytical chemistry expertise to rewrite SOPs for method applications and GLPs for laboratory tasks resulting in harmonized processes and improved workflow.

• Skilled in the application of LC/MS/MS in clinical laboratory settings.

The Dow Chemical Company, San Diego, CA 2000 - 2007

BIOANALYTICAL CHEMIST

Responsible for analytical method development and laboratory support including maintenance of GC (FTIR and MS), HPLC (UV and MS), NMR, UV and IR instruments. Served as Ethanol Steward and Alternate Radiation Safety Officer (ARSO); performed inspections and reported on compliance.

• Evaluated project timelines, prioritized tasks, and effectively performed analytical method development and analyses of fermentation, molecular biology, and chemical products; optimized and advanced the progress of numerous customer target protein projects in a timely manner.

• Efficiently scheduled method development; qualified, validated, and developed analytical methods in preparation for a wide range of production samples; achieved a high degree of productivity as a result of organizational and process expertise.

• Successful experimental efforts resulted in the production of a provisional patent and publication of material related to the production and purification of transesterified glycol ethers by Pseudomonads and Candida antarctica lipase.

Gen-Probe, Inc., San Diego, CA 1999 - 2000

SENIOR RESEARCH ANALYST

Created analytical method development and performed validations for raw materials and pharmaceutical end products; utilized HPLC/UV to quantitate preservative formulation in pharmaceutical end product entering Stage 1 clinical trials.

• Contributed knowledge and expertise to document review, method qualification and development, and employee performance review committees to promote quality decision making processes.

Alliance Pharmaceutical Company, San Diego, CA 1997 - 1999

RESEARCH SCIENTIST

Created draft stability study protocols and analysis procedures for drug products entering Stage 1 clinical trials. Revised synthetic route for carbon-14 labeling of cellulose to provide radio-labeled carboxymethylcellulose.

• Positively impacted workflow and process standardization; conducted both HPLC/MS and GC/MS analytical method development and quantitative analysis of fermentation media time samples in a manner allowing the use of SOPs for other drug products entering Stage 1 trials with minimal changes to analytical procedures.

• Utilized GC/MS to analyze and quantitate perfluorocarbon process impurities in pharmaceutical end product entering Stage 1 clinical trials, resulting in improved data quality.

Nutrasweet- Kelco Company, San Diego, CA 1990 - 1997

RESEARCH SCIENTIST

Leveraged creativity and technical expertise to successfully develop analytical methods and applications for alginate polymers and microbiological-produced fatty acid. Developed GC and HPLC method validations to accurately quantify highly unsaturated fatty acid in human consumable product.

• Conducted method development and presented data on NMR methods and studies resulting in the characterization of mannuronic/guluronic block ratios in alginate polymers and advancement of a human consumable product production. Examined biological fermentation pathways of marine algae using carbon-13 labeled media (HPLC/MS).

• Optimized the characterization of mannuronic/guluronic block ratios in alginate polymers by creating and implementing an improved NMR method which resulted in a more efficient determination of aqueous solubility and solution viscosity.

EDUCATION & AFFILIATIONS

BACHELOR OF ARTS, CHEMISTRY - UNIVERSITY OF CALIFORNIA, SAN DIEGO

Undergraduate Research Scholar: Synthesis and Characterization of Organometallic Product

AFFILIATIONS: Member - American Chemical Society-over 20 years / HPLC-7 years

ARTICLES & PUBLICATIONS

Article entitled “Kinetic Model Development for the Enzymatic Transesterification of +-1-n-butoxy-2-propanol into (R)-1-butoxy-2-propanol acetate using +-1-methoxy-2-acetoxypropane as an acyl donor” submitted for publication. (Awaiting publication).

Published article entitled “Location of the o-Acetyl Group in Welan by the Reductive Cleavage Method” (Carbohydrate Research, 224, 1992, p 337-341)

Published article entitled “Location of a Second o-Acetyl Group in Xanthan Gum by the Reductive Cleavage Method” (Carbohydrate Research, 241, 1993, p 321-326)



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