NICK RAIE

32913 Regents Blvd. * Union City, CA 94587

Home: (510) 324-5686 * Cell: (510) 828-9646 * E-Mail: nra42dc6@westpost.net

Experienced manager of analytical, bioanalytical and QC laboratory operations an

d quality systems supporting clinical, non-clinical studies and lot release test
ing.
Innovative and versatile biotechnology professional with broad expertise support
ing the pharmaceutical and biotech industries. Comprehensive knowledge of labora
tory operations and quality systems supporting development, validation, non-clin
ical, clinical studies and marketed products. Excellent analytical/problem-solvi
ng abilities. Highly motivated, results-oriented team player with exceptional in
terpersonal and team building skills.
Key Qualifications:
Extensive experience in analytical and bioanalytical method development and vali
dation supporting non-clinical, clinical, lot release testing and quality contro
l.
Strong managerial experience in the areas of QC microbiology/EM testing, QC lot
release of marketed products, PK and immunogenicity testing supporting both clin
ical and nonclinical studies.
Significant technical writing skills as well as process improvement experience.
Working knowledge of cGMP, ICH, and GLP regulations.
Co-author of several scientific publications (details and publications available
upon request).
PROFESSIONAL EXPERIENCE:
Elan Pharmaceuticals, Inc. * SSF, CA Aug 2006 a" Mar 2009
Senior Manager, Bioanalytical Development
aDeveloped, validated and reviewed bioanalytical methods supporting clinical stu
dies, (phase I, II and III), under GLP regulations.
aEffectively lead a bioanalytical group responsible for method validation and te
sting of human specimen for macromolecules and biomarkers by ECL and MSD platfor
ms.
aAddress audit findings and actively lead process and quality system improvement
projects
aRevise critical SOPs for compliance with GLP and ICH guidelines.
aLead a cross-functional team to design bioanalytical sample QC process
acGMP and GLP training.
Abgenix, Inc. / Amgen, Inc. * Fremont, CA Apr 2005a"Jun 2006
Manager, Analytical Method Validation/Quality Engineering
aReviewed and approved validation protocols and reports of analytical methods an
d laboratory equipment supporting QC, process sciences, and manufacturing under
GMP and ICH.
aContributed to BLA filing and PLI preparedness. Participated in PLI audits.
aProvide technical and compliance feedback on analytical development, analytical
method transfer and validation projects
aRevised Quality Engineering SOPs

Abgenix, Inc. * Fremont, CA

Associate Bioanalytical Scientist,
Jan 2002-Mar 2005
Pharmacokinetics and Toxicology
aManaged day-to-day activities of bioanalytical laboratory group supporting clin
ical and non-clinical studies.
aOversight of development and validation of immunoassays (ELISA, ECL, CL, IRMA,
RIA)
aLaboratory design and acquisition of new lab technologies and equipment.
aAuthored technical SOPs and SOPs necessary to establish GLP compliance and bioa
naytical reports
aPrincipal Investigator for numerous non-clinical and clinical studies.
aHosted compliance audits and addressed compliance observations.
aCo-authored publications and abstracts.
Abgenix, Inc. * Fremont, CA
Senior Research Associate/Supervisor, PK-Tox Aug 2000-Dec 2001
aManaged bioanalytical laboratory activities and staff supporting clinical and n
on-clinical studies which included development and validation of immunoassay.
aManaged immunoassay development and validation contracts with CROs.
Baxter Healthcare, Inc. * Hayward, CA Nov 1998 a" Aug 2000
Senior QC Associate/QC Immunology
aIn-process, raw materials, and lot release testing supporting a marketed produc
t (GMP).
aPerformed analytical method, equipment, and software validation.
aMember of the Quality Management Board (QMB).
aReceived training in cGMP, Total Quality Management, and Quality Leadership Pro
cess.
Cell Genesys, Inc. * Foster City, CA Nov 1993 a" Nov 19
98
RA - RAII a" Senior QC Associate, Assay Development
aTrained and supervised four analysts in the area of QC microbiology.
aAuthored all QC microbiology SOPs and protocols per USP.
aConducted facility PQ validation planning and testing and wrote final IOPQ vali
dation report.
aPerformed BI-autoclave validation, EM monitoring for normal operations, media f
ills/cell banks, growth promotion testing, final product sampling, sanitant vali
dation, sterility/ mycoplasma testing, QC data trending, and managed deviations/
CAPA.
aPerformed assay development and validation ELISA and cell-based methods in supp
ort of gene therapy products in clinical trials phases I and II.
UC Davis (CVDLS) * CA Aug1990 a" Dec 1992
Lab Assistant II and Staff Research Associate II
aDeveloped an ELISA to test for anti Hemophilus paragallinarum in sera.
aPerformed literature research, antibody production, assay development, statisti
cal design, and data analysis.
EDUCATION:
Master of Science (1990)
California Polytechnic State University * Pomona, CA