Microsoft Office Management

Professional Summary

A CRO chemist seeking a position which complements my professional and educational background, and utilizes my proven skills as an accomplished Associate Scientist, HPLC Analyst, and Laboratory Manager. Searching for an opportunity to further enhance my knowledge, contribute to a dynamic organization, and continue my career in the professional scientific industry.

Skills

GLP, GCP, OECD, FDA, cGMP (5 yrs)

Small molecule, biologics development and validation ( 7 yrs)

HPLC, LC/MS/MS and AMS analytical platforms (5 yrs)

Staff Training/Mentoring (3 yrs)

Contract Research Organization ( 5 yrs)

Management/Leadership/Supervisory (1 yrs)

Experience

Analyst II July 2012 – Present

Xceleron, Inc. – Germantown, Maryland

Supervisor: Todd Pankratz, MS, Director of Lab Operations

Write protocols, methods, standard operation procedures, and submission documents independently

Conduct standard and advanced laboratory activities independently

Analyze raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods

Perform protein precipitation, liquid-liquid extraction, solid phase extraction, wet-chemistry extraction procedures

Independently set up and operate lab equipment, conduct instrument and analytical method troubleshooting

Metabolite Profiling, Mass-balance, and IV-PK studies

SOP writing and revising

HPLC method development, validation, and clinical sample analysis, maintenance, and trouble-shooting

Data processing

Design experimental studies and write reports with minimal supervision

Compliance of all lab tests under GLP/GMP guidelines

Accessioning radio-labeled samples and reference material

Procurement of all test materials and lab supplies

Quality Control checking of compliance of data

Associate Scientist October 2010 – July 2012

Eurofins Medinet – Chantilly, VA

Supervisor: Seema Garg, MS, Director of Bioanalytics

Perform extraction procedures, following laboratory protocols and SOPs on biological and chemical samples for LC/MS/MS analysis in various matrices (urine, feces, plasma, whole blood, serum)

Sample preparation/extraction methodology, protein precipitation, liquid-liquid extraction, solid phase extraction, wet-chemistry assays and 96-well plate based assays.

Worked on multiple projects simultaneously with stringent timeline requirements, set priorities with study directors and management to ensure all milestones and deadlines were meet

Procurement

Establish and maintain effective relationships with team members

Operate, maintain, troubleshoot, HPLC/UPLC (Waters, Agilent 1100/1200) systems

Operate, maintain, troubleshoot Mass Spec (API 5000 and 4000)

Data analysis and processing

Research and recommend corrective actions for out-of-specification and out-of-trend results

Strong working knowledge of global database systems and MedLims sample tracking

Strong working knowledge of regulatory requirements pertaining to GLP, GCP, FDA

Manufacturing Associate August 2010 – Ocotober 2010

Omnia Biologics – Rockville, Maryland

Manufacture and process development services for companies and clients

Culture cells, cell banking, aseptic filling

Perform all procedures following GMP guidelines and regulations

Write and revise SOP and MSD documents for procedures and materials

Answer phone calls from clients and companies

Data analysis

Education

George Mason University August 2005 – January 2010

B.S. Chemistry

Training

NCARSQA: Basic Training – Good Laboratory Practice March 2011 NCARSQA: Advanced Training – Good Laboratory Practice May 2012 Analyst 1.4.2 Agilent ChemStation OpenLab Agilent HPLCs (1200; 1100 series), Waters UPLC AbSciex Mass Spectrometers (4000, 5000) Perkin Elmer Liquid Scintillation Counter PerkinElmer 2400 Series II CHNS/O Analyzer Perkin Elmer Sample Oxidizer Data analysis GLP cGMP GCP FDA regulations Procurement SOP writing and revision Method Development Microsoft Office Sample receiving Project Management GC/MS LC/MS FTIR QA QC R&D

Contact this candidate