Eddie N. Kast

**** ******** ***, *****, **, *****

Home/Cell: 209-***-****

abmm45@r.postjobfree.com

EXPERIENCE:

Scientist, Analytical Chemistry (May 2008 – April 2010)

Trinity Biosystems

• Developed, qualified, and analyzed small molecules, peptides, and proteins by HPLC

methods (RP, AEX, CEX, SEC, peptide map, HIC)

• Assisted in formulating peptides and small molecules for pre-clinical studies to generate

PK and PD data

• Lyophilized drug products for stability study

• Disintegration testing of enteric capsule coatings to determine the release time in the

stomach

• Evaluated the stability of the drugs in the stomach environment

• Lot release testing for pre-clinical samples by different HPLC methods

• Developed a method for multiple reaction monitoring (MRM) for peptides using the

Applied Biosystems/MDS SCIEX Linear Ion Trap (LIT) 4000 Q TRAP® LC/MS/MS

System

• Supported R&D, Cell Culture, Purification, Formulation, and Stability groups

with analytical testing

• Assisted in generating Certificate of Analysis (CofA) for drug products

• Wrote method protocols, technical reports, and study summaries

Manager / Scientist, Analytical Chemistry / QC (May 1995 – May 2008)

PDL BioPharma Inc.

• Participated in early development through commercialization of one small molecule as a

lead analytical scientist.

• Developed and validated HPLC based methods for small molecules according to

USP/ICH guidelines

• Analyzed small molecules by KF titration, dissolution, FT-IR, GC, LC/MS, and CE under

cGMP conditions

• Evaluated degradation pathway and stability study of small molecules

• Approved IQ, OQ, and PQ protocols and results for HPLC instruments in the Analytical

Chemistry group.

• Involved with QC lot release testing for clinical products, validated assays, and OOS

investigations. Familiar with LIMS and EDMS systems.

• Organized, Performed, and Wrote Technical Report for the stability of monoclonal

antibodies to determine the major degradation pathways such as fragmentation, aggregation,

oxidation, and deamidation. The studies were performed under accelerated, long term, and

photostability conditions.

• Developed and Qualified iCIEF, cIEF, CE-SDS, CZE, and HPLC based methods

(Peptide Mapping by LC/MS/MS, Oligosaccharide Mapping, Monosaccharide

Quantitation, Sialic Acid Determination, Cation Exchange Chromatography, Size

Exclusion Chromatography, and Deamidation Quantitation) assays followed the ICH

guidelines.

• Involved with method development of Binding Potency by Flow Cytometry and

Functional Potency, Circular Dichroism, Differential Scanning Calorimetry,

Coulometric Karl Fisher, and Fluorescence Detection assays for protein stability and

evaluating effects of excipients in formulation.

• Trained other scientists and associates to perform LC/MS/MS using Finnigan TSQ7000

ESI Mass Spec and determination of the intact monoclonal antibody mass by MALDI-TOF

and Q-TOF analyses.

• Participated in writing the comparability protocol for site and process changes for a

monoclonal antibody to initiate Phase II/III clinical studies.

• Wrote the Physico-chemical and Functional comparison in the CMC section of IND, IND

Amendments, CTX, IMPD, and EOPI filings for monoclonal antibodies.

• Familiar with FDA and ICH guidelines.

• Collaborated with R&D, Cell Culture, Purification, Formulation, QC, Pre-clinical, Project

Management, and Regulatory to advance drug products toward BLA filings.

• Fully trained with cGMP and GLP procedures.

Research Associate, Analytical Chemistry /QC, (July 1992 – April 1995)

Celtrix Pharmaceuticals Inc.

• Involved in the proteins process scale –up from 2L through 1000L for E.coli.

• Purified recombinant proteins and characterized proteins from each step with various

HPLC techniques.

• Performed peptide synthesis and protein sequencing

• Identified the disulfide bond assignment with peptide mapping and mass spec.

• Developed and Wrote Technical Reports for IEF, Western Blot, ELISA, SDS-PAGE with

Silver Stain, Colloidal blue, and Coomassie blue.

• Performed QC validation tests under cGMP for SDS-PAGE and HPLC methods.

• Raw material purity determination by GC under cGMP conditions.

EDUCATION: B.S, Biochemistry

San Jose State University, San Jose, California

References Available Upon Request

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