Summary of Qualifications:

Extensive experience in pharmaceutical analysis, method development/validation, method transfer

Working knowledge of various analytical techniques and instrumentation including maintenance, calibration and troubleshooting of the analytical instruments

Practical knowledge of HPLC, ICP, GC, FTIR, UV-VIS, and compendial testing (USP, EP, BP, FCC, JP)

Detail and result oriented; ability to work under minimum supervision in a GMP environment

Flexible and multitask oriented, learn quickly new instrumentation and techniques

Always meet deadlines due to high productivity and effective time management

Conduct laboratory training, assist chemists and technicians with daily assignments

Accomplishments:

Performed validation of an HPLC stability indicating assay for determination of l-Leucovorin and related compounds in ISO-Vorin™ for injection, currently approved by FDA (for Spectrum Pharmaceuticals)

Developed and validated UPLC method for the determination of seven actives in cosmetic products

Performed Validation of Combigan 10035X (unpreserved) formulation for Allergan, Inc.

Performed Validation for related compounds determination for Carboplatin in the Drug Substance and Drug Product by HPLC for TEVA Pharmaceuticals

Performed annual OQ & PQ on eight Waters HPLC 2690/996 & 2695/2487 instruments, and PQ on Hanson Dissolution Apparatus saving the company more than $25, 000 annually without sacrificing quality

Related Instrumentation:

HPLC: Waters 2690/2695 * Waters 996(PDA)/2487(Dual λ)/2410(RI) / Empower Pro Software

UPLC: Waters Acquity H-class / Empower Pro Software

GC: Varian CP 3800 (COMBIPAL w/head space (FID & TCD detectors) / Star Workstation 6.0

FTIR/ATR: Thermo Nicolet Atavar 360 FTIR w/Smart Orbit ATR Accessory / OMNIC Software

ICP: iCAP Thermo Fisher Scientific 6000 / iTEVA Software

UV-VIS: Beckman DU 800 * Shimadzu 1601

KF: Brinkman Metrohm; Brinkman Titrino; Metrohm Titrando/Tiamo

Dissolution Apparatus SR8-Plus (Hanson Research)

SOTAX HT1 and SOTAX HT2 (Tablet hardness and Disintegration Apparatus)

Computer Software: Windows 10 * MS Office (Excel 2016, Word 2016) * LIMS

Professional Experience:

Senior Analytical Chemist

October 2004 – May 2018

BioScreen Testing Services, Torrance, California

Initiated and performed method development/validation of analytical methods

Performed special projects, assays, using HPLC, GC, ICP, UV-VIS, Karl Fisher, dissolution apparatus, FTIR,

to insure compliance with specifications, policies, FDA, GMP, GLP, ISO & ICH regulations and guidelines

Conducted analytical testing of various pharmaceuticals including raw materials, cosmetics, API/DP (Assay and

Impurities, Content Uniformity), following USP/NF, BP, EP, JP, FCC, in-house and client's methods

Wrote new and revised chemistry methods and SOPs, method validation protocols and reports

Troubleshooted instruments and procedures within the department as needed

Performed laboratory training and reviewed laboratory notebooks as needed

Assisted chemists with daily assignments including method development/validation

Quality Control Chemist II (contract)

March 2004-September 2004

Bachem California, Inc., Torrance, California

Performed analytical testing of peptides (in-process, finished products, validation, forced degradation, stability studies)

by HPLC (assay, purity, Ac/TFA) to insure compliance with specifications, policies, and GMP requirements.

Performed peer review as needed.

Quality Control Chemist II

Feb 1997- November 2002

Leiner Health Products, Inc., Garden Grove, California

Performed duties to inspect and analyze vitamins and nutritional supplements submitted for testing, including finished products, raw materials, in-process, stability, and validation samples to ensure compliance with specifications, company procedures, policies, and regulatory requirements.

Performed analytical and physical testing (dissolution, titration, UV-VIS, HPLC). Followed all SOP, GMP, USP, and lab safety procedures.

Responsible for laboratory training in wet and instrumental analysis, peer review, calibration of UV-VIS spectrophotometers. Member of Calibration Team.

Education:

Chemical Pharmaceutical Institute, St.-Petersburg, Russia

Master of Science in Chemistry/Pharmaceutical Engineering

Awards:

2007 Quality Award

2009 & 2014 Service Awards

Poster Presentation:

Validation of an HPLC Stability Indicating Assay for the Determination of ℓ-Leucovorin and Related Compounds

in ISO-Vorin™ for Injection

Professional Development:

LC Resources Inc. Workshop The Practice of Modern HPLC, La Jolla, CA

Certification in High-Performance Liquid Chromatography

UCSD Extension, La Jolla, CA, Course completed: Analytical Chemistry in Pharmaceutical Industry

Waters Educational Seminar Empower2 Software Advanced Topics, Irvine, CA

Waters Training Course Fundamentals of LC/MS, Certificate of Training, Irvine, CA

Waters Seminar Effective UPLC Implementation, Irvine, CA

Waters Seminar Developing LC Robust Methods, Irvine, CA

Waters Webinar Practical Aspects of Transitioning to UPLC in the QC Laboratory

Project Management, Pryor Seminars, Certificate of Attendance, Long Beach, CA

Attended ongoing educational seminars at Waters and Phenomenex; SCPDG presentations

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