Obtain a management position within a biotech/pharmaceutical company where I can energetically utilize my knowledge of cGMP laboratory systems, microbiological and analytical analysis in concert with relevant work experience.
Microsoft Word, PowerPoint and Excel to analyze data through graphing
Proficient in microscopy and microbiological techniques such as gram-staining, plate streaking and protein
Performed immunological techniques such as ELISA, western blot, gel-electrophoresis (SDS-PAGE) and
Developed and maintained bacterial colonies to isolate and identify potentially pathogenic bacteria
Certificate of training in the cGMP-GLP training program with proficiency above 85%
Used PowerPoint to give presentations of scientific nature
Ability to work independently and as a strong team member
Senior Scientist, 01/2008 to CurrentGlaxoSmithKline － King of Prussia, PA
Act as Lab Administrator to create and modify user accounts and backup GMP data for Biochemistry and Microbiology groups Act as a team leader for coordinating in-process and release testing as well as scheduling analysts for separation assays Train analysts on analytical methods as needed Troubleshoot instrumentation as necessary Keep laboratory equipment software versions current and install new software as needed Execute validation protocols on laboratory equipment Work with outside vendors as well as the validation team to bring in new technology and release for GMP use Schedule instrumentation for calibrations and review all documentation post calibration Utilize HPLC, UV/vis and SOLOVPE to determine protein concentrations on quick turnaround in-process samples Categorize protein aggregates and fragments by separation techniques such as Affinity, SEC, cIEF, NGHC and RP-HPLC Analyze in-process samples and Bulk Drug Product to determine residual host cell DNA using qPCR Generate an amino acid profile on raw material media using HPLC Create change controls as needed and execute action items to progress to completion Complete OOS & OOT investigations on laboratory equipment Performed heavy metal analysis on daily water samples using the current USP and European Pharmacopeias Analyze formulation buffer preparations Participate in tech-transfer and method qualifications and author qualification reports Participate in experimental studies and CAPA's as directed by manager Perform peer data review of laboratory experiments Utilize LIMS for data entry and retrieval Train analysts on the use of EMPOWER for chromatographic analysis and act as a lead user Coordinate sample disposal of tested and reviewed laboratory samples Worked on updating raw material specifications in the documentation library Update analytical instrument methods to comply with current standards and practices Act as laboratory lead representative performing laboratory walkthroughs to ensure laboratories are in a state of audit-readiness as well updated with all current safety regulations Attend seminars and refresher courses on practicing GMP Perform daily calibrations on laboratory equipment as needed.
Chemist, 01/2005 to 01/2008Siegfried Pharmaceuticals － Pennsville, NJ
Analyzed in-process, finished product and stability samples by HPLC and GC on a daily basis as well as performing wet chemistry techniques Performed a wide variety of analytical techniques such as polarimetry, colorimetry, melting-range, FT-IR, UV/vis and Karl Fischer titrations Participated in out-of-specification/out-of-trend investigations Qualified the purity of in-house reference standards against USP standards Assist in training of laboratory personnel on instrumentation, methods, and cGMP Used computer program LIMS for data entry and retrieval as well as Totalchrome for chromatographic analysis Perform peer data review Made retains of all production samples and maintain the inventory of retain samples Calibrate and maintain laboratory equipment and instrumentation on a daily basis Conducted chemical and physical laboratory tests under USP guidelines for several controlled substances and noncontrolled substances Prepared and standardized reagents used in laboratory experiments Meticulously documented findings in the proper notebook.
Quality Control Chemist, 01/2004 to 01/2005David Michael and Company － Philadelphia, PA
Gained experienced with common laboratory practices, equipment, and analytical techniques in accordance with cGMP and cGLP Analyzed incoming raw materials by GC Prepared reagents, solutions, and samples for HPLC and GC analysis Compiled and documented test findings and results Conducted chemical and physical laboratory tests utilizing wet chemistry techniques.
MBASaint Joseph's UniversityPharmaceutical and Healthcare Marketing Program
BA:Biology microbiology,December 2005Thomas Edison State UniversityBiology microbiology
acid, backup, Biochemistry, calibration, chemistry, data entry, DNA, documentation, ELISA, experiments, fashion, FT-IR, GC, GMP, GLP, HPLC, inventory, laboratory equipment, laboratory tests, team leader, LIMS, Marketing, materials, Excel, PowerPoint, Microsoft Word, PAGE, personnel, presentations, progress, protocols, quick, safety, scheduling, scientific, seminars, Six Sigma, specification, trend, Troubleshoot, UV, validation, author