Luy Khan
132 Birchview Dr
Piscataway,NJ 08854
Phone: (347)-743-1280
luykhan@yahoo.com
______________________________________________________________________________
EDUCATION:
Masters in Microbiology .credits completed 2003, Thesis work from Nov 2010-2012
Long Island University, New York
Bachelors (M.B.B.S) 1997
Kasturba College, Manipal, India
WORK EXPERIENCE:
Consultant ;Piscataway NJ Jan 2011-Present
Park Avenue Group LLC
QC/QA Microbiology Consultant
 USP,cGMP ,FDA, CFR 21 QC Microbiology lab regulations guidance.
 SOP writing, updating and editing.
 Equipment, product management and validation protocol.
 QC Lab setup, Audit and work flow consultation.
Imclone Systems Eli lilly; Branchburg, NJ July 2007-Nov 2010
Senior Analyst-QC Microbiology
• Performed highly skilled and complex biological tests (eg: Bioburden, Sterility,
KQCL endotoxin testing) on a wide range of substances from buffers to
finished drug products.
• Conducted routine and non-routine analysis of in-process materials, raw
materials, environmental/water samples, finished goods and stability
samples by appropriate biochemical or microbiological methods as assigned
by the Supervisor.
• Validation of equipment and procedures.
• Performed routine QC responsibilities as needed.
• Applied cGMP practices during execution of all work tasks.
• Worked independently with moderate supervisory guidance.
• Responsible for documentation.
• Attended all QC meetings.
• Provided QC support for all submitted materials.
• Responsible for trend report generation, Acquisition and Decommission
&Change control.
• Wrote S.O.Ps , CAPAs, Forms, reviews and articles.
• Clean and sterile room environmental monitoring.
• Participating in QC, QA, Safety group and FDA Lab audit team meetings.
• Method validation and Equipment calibration.
• Training microbiologists and lab techs.
Nature's Value Inc; Long Island, NY 2004-2007
QC Micro - Lab Supervisor
• Coordinated microbiological testing, release of product, and testing.
• Wrote and revised procedures and protocols.
• Prepared investigative reports and data summaries.
• Performed employee scheduling, training and evaluations.
• Reviewed daily testing in the Quality Assurance laboratory.
• Performed technical review of filling batch records to assure quality of aseptic
processes.
• Compiled and organized microbiological documentation for release of finished
product and reviews for completeness and accuracy related tests on finished
goods and raw materials.
• Participated in investigation of environmental monitoring excursions and out-ofspecification events.
• Wrote and revised SOP's.
• Participated in GMP audits and worked independently.
• Identified and resolved technical problems through investigations and special
testing.
• Reviewed and approved environmental monitoring data and
laboratory equipment and instrumentation records, DI water testing
and conductivity.
• Identified microbial isolates using gram stain, biochemical tests and automated
identification systems.
• Read and interpreted microbiological cultures and other Environmental
Monitoring, Sterility tests, growth promotion, Microbial Limits Tests, Vitek
under USP 29,cGMP, GLP, FDA Guidelines.
• Tests method validation, training of microbiologist.
• Prepared and maintained microbiological media, reagents, quality control
organisms and stock cultures in accordance with SOPs and GLP/GMP
regulations.
• Performed quality control testing of microbiological reagents, differential and
selective media and test supplies.
Brunswick hospital, Amityville, NY 2004 (Weekends)
Clinical Microbiologist:
• Conducted tests, cultivate, isolate and identify bacteria and other
microorganisms from Blood, Abscess swabs,CSF &urine samples.
• Used Vitek 1 automated system.
• QC paper work, scheduling, & training in the Hospital Microbiology Laboratory.
Analytical Food Laboratory, Dallas, TX 2004
Microbiologist (Contract)
• Conducted tests, cultivate, isolate and identify bacteria and other
microorganisms from water, pharmaceutical, environmental and food
samples.
• Participated in GMP audits and worked independently.
• Prepared and maintained microbiological media, reagents, quality control
organisms and stock cultures in accordance with SOPs and GLP/GMP
regulations.
• Maintained documentation, data and review.
• Performed various tests and record documentation, quality control,
antimicrobial tests, PCR Biology, entered Records
• Maintained stock culture, media and performed daily maintenance in the
laboratory.
• Trained Microbiologists and technicians to be in compliance with Good
Manufacturing Practice (GMP) and company's standards for quality.
Pfizer Pharmaceutical, Brooklyn, NY 2003 (Contract)
Laboratory pharmaceutical technologist
• Inspected products, hands on in the lines and data collection.
• LAL, Bioburden and Antimicrobial Effectiveness Tests & Media preparation.
• Culture transfer & maintenance.
• Equipment scheduled maintenance, cleaning.
• Quality control, rotated in deferent departments, manufacturing, and packaging.
Long Island University, New York, NY 2003
Biology Laboratory Associate Supervisor
• Quality control
• Supervised classes and laboratory functions.
• Prepared, compounded, poured and stored from deferent components; Stains,
Reagents, Agar, Broth, Others: Distilled water, Saline.
• Microscope operation, Autoclave -dry and liquids, Centrifuge.
• Protein gel electrophoresis, Lab scales and balances, Laboratory equipment
calibration.
SPECIAL SKILLS:
• MODA, Trackwise, Pilgrim, elm, MS Word, Excel, Access, PowerPoint and all
Internet and lab software Applications.
MEMBERSHIPS:
American Society for Microbiology