Quality Control Assurance

STAN KIM

**** ****** *** ******* ** ***** 425-***-**** ****.***@****.***

SUMMARY

** ***** ** ******** ********** including development and routine execution of cell-based assays for characterization, in-process and release testing to support clinical and commercial operations.

SME for computerized systems validation including lab automation and multiplexers.

Led a team of research associates at a CMO in Maastricht, Netherlands for clinical QC immunoassay testing for safety, potency and identity testing.

Knowledgeable and experienced with microbial/aseptic techniques including identification and environmental monitoring.

EXPERTISE

Project leader Management Assay Development Characterization

Technology & Method Transfer Quality Control Stability Release

Technical Reports Root Cause Investigations CAPA Impact Assessment

Virology Computerized Systems Validation SME

Lab Automation Programming Microbiology

PROFESSIONAL EXPERIENCE

Sep 2013 - Present

SNBLUSA – Associate Scientist, Virology/Molecular, Analytical Biology Everett, WA

Responsible for providing technical and scientific leadership in the Virology and Molecular Biology department.

Subject Matter Expert for the Hamilton MicroLab Star Robotics Automation Workstation including system validation.

Responsible for method creation and assay development on the Hamilton MicroLab Star Robotics Automation Workstation.

Responsible for development of the Hamilton Microlab Star Robotics Automation Workstation training program.

Subject Matter Expert for the Bio-Rad Multiplex including system validation.

Planning/executing validation and analytical projects.

Overseeing implementation and validation of department equipment, analyzers, software and methods.

Overseeing/maintaining study conduct according to GLP regulation/documentation of study protocols and analytical study plans.

Analysis of study/project data and reports for internal and client sponsored GLP and non-GLP preclinical drug studies.

Writing/drafting and peer review of technical documents such as validation plans, data/analysis reports, protocols, SOPs.

Development, characterization and implementation of immunoassays including complement ELISAs, Cytokine/Chemokines, serological, Western blotting, PCR and other projects to support internal and client sponsored studies.

Responsible for responding to inquires from clients and other relevant parties regarding scientific/technical aspects of projects.

Apr 2012 – May 2013

Pharmacell – Quality Control Supervisor Maastricht, The Netherlands

Responsible for all clinical QC immunoassay testing (safety, potency and identity tests) and documentation compliant to cGMP.

Reviewer/approver of QC related batch documentation.

Completing non-conformance, planned deviation, corrective and preventive actions, change control reports.

Drafting/revising SOPs and methods.

Assay and analytical method trending (KPIs).

Team management including personnel training and trouble-shooting for all QC activities.

Cross-departmental cooperation/interaction from sample submission to Manufacturing to report submission to Quality Assurance.

Preparation, review and submission of QC reports to ensure timely release of final product.

Familiar with Euduralex (EU) GMP regulations. Worked closely with QP (Qualified Person) to release batches for infusion of product to patient.

Jun 2010- Jan 2012

Dendreon – QC Bioassay Associate Seattle, WA

Knowledgeable and trained in performing in-process and final product testing of samples using flow cytometry, ELISA, endotoxin, Gram stain, manual differential, complete blood count, and viability, Apheresis inspection, and receiving EM and BacT.

Performed various immunotherapy assays in the Dendreon pipeline including sipuleucel-T and DN24-02 assays and operation qualifications.

DN24-02 stability studies.

Comparability study for ELISA.

Technical writing of justifications for test methods and operating procedures for DN24-02.

Author for DN24-02 training proficiencies for analyst, reviewer, and trainer for Cellometer, ELISA, and Endotoxin assays.

Identifying and documenting process deviations, change controls, and corrective actions (CAPAs).

General lab support, equipment PM’s, ordering reagents, troubleshooting, archiving reports and data.

2008-2010 Bayer Healthcare – QC Microbiology Associate Seattle, WA

Environmental monitoring – purification/fermentation – viable, non-viable, surface.

Microbiological assays including bioburden, endotoxin, pH, conductivity, TOC, micro id.

Media qualification, preparation, and growth promotion.

LIMS systems data entry and review.

Monthly file review – analysis and interpretation of results.

Annual data reconciliation projects.

General lab support, equipment PM’s.

2006-2008 Biorad – QC Chemist Redmond, WA

Evaluation and enumeration of microorganisms on specific media for the surface, particular (air), and viable (personnel) monitoring programs, following the standard operating procedures (SOP's).

Collection air samples and analysis, using a particle counter, and interprets the bacteria and fungus counts on the agar strips, as well as entering the results into a database system.

cGMP trained following procedures for all FDA controlled documentation.

BSL-3 training.

Performs the Environmental Monitoring testing for the water-monitoring program by operating and maintaining Total Organic Carbon (TOC) analyzer and pH meter.

Chairperson for the Environmental Task Force and provides for Laboratory staff by performing general laboratory duties and functions.

Gel electrophoresis of GP41 and GP160 proteins; HPLC training USP preservative challenge; Bioburden.

Evaluation and performance of sub-culturing microorganisms for identification.

2005-2006 DiStefano/Chateau Ste Michelle – QC Chemist Woodinville, WA

Perform daily analysis of samples following Standard Operating Procedures. Analysis performed include alcohol concentration, Brix, Titratable Acidity (TA), Volatile Acidity (VA), Free and Total SO2 concentrations, Residual Sugar (RS), heat/cold stabilization, O2 levels, and percent solids.

Prepare and standardize stock solutions for analysis.

Prepare chemical additions according to calculations.

EDUCATION:

1998-2004 Walla Walla University - College Place, WA

B.S., Health Sciences, Chemistry minor

SOFTWARE SKILLS:

Data Analytics: LIMS, KC4, GEN5, Bioplex Manager, MSD

Graphing/Visualization: AutoCAD, Visio

Microsoft: Outlook, Word, Excel, Powerpoint, Sharepoint

Automation: Venus 3 (Hamilton)

Flow Cytometry: MXP (Beckman Coulter FC500), BD FACStation

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