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Analysis Project Manager

Location:
Bloomfield, New Jersey, United States
Posted:
November 08, 2018

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Resume:

PETER LUK

** *********** ****

North Brunswick, NJ 08902

Email: ac7m63@r.postjobfree.com

Cell: 862-***-****

Home: 973-***-****

PROFESSIONAL SUMMARY

Dedicated and focused professional scientist with finish products and stability experience with emphasis on solid, liquid, and ointment dosage forms.

Knowledgeable in Method Development and Method Validation.

Expertise in HPLC, dissolution, and elution USP 4 & 7 testing methods.

Thorough knowledge of USP/NF and ICH guidelines.

Demonstrated ability to facilitate multiple laboratory functions such as lab audits, inventory control, and laboratory cleanups

Ability to multitask: Execute multiple projects with short deadlines.

Outstanding interpersonal and communication skills: superior accuracy in documentation of laboratory results and findings, data charting, and other documentation.

Solid working knowledge and troubleshooting of variable laboratory equipment.

Monitor and storage of samples for stability testing/profiles.

INSTRUMENTATION

HPLC (Waters, Hewlett Packard, Alliance, Agilent, and Dionex), PDA (Waters), Refractometer(Waters), Mass Spectrometer(Shimadzu), GC (Hewlett Packard), KF Titrator (Metrohm and Aquastar), FTIR (Beckman and Nicolet), pH meter (Orion and Corning), Melting point apparatus (Mettler and OptiMelt-SRS), AA spectrophotometer (Shimadzu, Varian, Beckman), UV/VIS spectrophotometer (Beckman), Dissolution Apparatus 1,2, 4, & 7 (Van Kel, Sotax, and Distek), Particle Size analyzer (Alpine and Roto Tap), Surface Area Analyzer (Gemini and Horiba),

COMPUTER

IBM PC’s with Windows applications, Pflask, Lotus Notes, Microsoft Excel, Microsoft Word, Microsoft Access, Expertease, Empower 2, Millennium 32, PeakPro, and Chemstation.

PROFESSIONAL EXPERIENCE

Purine Pharma, Massena, NY 01/2015 – 06/2015

Senior Analytical Chemist/QC Supervisor

Written and reviewed all SOPs and Validation Protocols for Quality Control Unit.

Tested and troubleshooter for all laboratory testing procedures.

Checked all completed laboratory reports.

Sent out all outside testing requests.

Calibrated and validated all in house laboratory equipment.

Ensure all laboratory personnel are currently and updated in training.

Responsible for special project testing for industry.

Monitor all laboratory calibration schedules.

Responsible for all raw materials, in process, stability products, and R&D formulation testing.

McNeil Consumer Health, Lancaster, PA 11/2013 – 12/2013

Analytical Chemist

Tested and troubleshot analytical methods for consumer products

Checked and corrected STPs and SOPs for QC laboratory

Ran cleaning validation methods for manufacturing machinery

Assisted in swabbing and collecting all cleaning samples

Analyzed all unknown anomalies during HPLC runs

GlaxoSmithKline, Parsippany, NJ 4/2012 - 4/2013 Analytical Research Analyst

Tested all consumer products on stability under USP and EP guidelines

Troubleshooter for HPLC systems

Generated reports and data to project manager

Supported formulation department in testing new project developments

Trending and monitoring all incoming consumer products.

Hospira Inc, Rocky Mount, NC 11/2011 - 1/2012 Consultant

Peered review all laboratory documents

Mentored laboratory analysts on laboratory practices and techniques

Responsible for final review of laboratory data and templates

Troubleshot all laboratory instrumentation

Generated reports and observations to customer

Reviewed all laboratory chromatograms for release

Laureate Biopharm Services, Princeton, NJ 5/2011 - 07/2011

QC Chemist (Contract)

Tested all raw materials, stability, and validation studies under USP/EP guidelines.

Followed cGMP guidelines and procedures.

Troubleshoot all laboratory instrumentation

Performed assays, TOC, ELISA, and endotoxin testing

Generated reports for customers.

Water testing under USP guidelines

Responsible for sampling for laboratory prior to testing.

Cleaning Validation

Cordis Corporation, Warren, New Jersey 07/2008 - 03/2010

Senior Chemist (contract)

Tested all in-process and developing devices for production, stability, and validation studies.

Troubleshooting all laboratory instrumentation down to the component level.

Validation of new testing procedure for raw materials and medical devices.

Performed assay, content uniformity, impurity profile, particle size analysis, and elution tests.

Responsible for testing complaint samples.

Generated reports and charts for product and stability profiles.

Presented data and findings in company meetings.

Othera Pharmaceuticals, Exton, Pennsylvania 1/2008 - 6/2008

Research Associate (project discontinued)

Involved in Method Development and Formulation of ophthalmic solutions and APIs within the phase 1, 2, and 3 of clinical research.

Responsible for the research and development of APIs for new drug discovery.

Involved in the validation of new drug products within the synthetic laboratory function, trend analysis of APIs, and evaluate the efficacy of new drug products.

Responsible for the monitoring and storage of finish products for stability testing.

Performed assays, impurity analysis, identification, FTIR, Karl Fisher analysis, melting point, osmolarity and pH for stability program of ongoing drug products.

Responsible for checking of notebooks and logging of laboratory supplies/COAs.

Produced data reports on current projects.

McNeill Consumer Health, Morris Plains, NJ 7/2007 - 12/2007

Analytical Chemist (contract)

Involved in the method validation and method development of liquid dosage forms for Visine products line using HPLC with differential refractometer.

Performed and evaluated assays and impurity analysis.

Knowledgeable in ICH, USP/NF, and cGMP guidelines.

Presented data reports and trend analysis on current projects.

McNeill Consumer Health/Pfizer, Inc., Morris Plains, NJ 7/2006 - 4/2007

Analytical Chemist (contract)

Annually trained in ICH, USP/NF, and cGMP guidelines.

Involved in the method development and method validation of Listerine, Rolaids, and Sudafed for consumer products line.

Performed assays, content uniformity, blend uniformity, dissolution, impurity analysis, method transfer, and method optimization utilizing HPLC, AA, and GC.

Other responsibilities include investigation reporting, pH meter calibrations, TLC analysis, monitoring of samples for stability testing, and data interpretation and reporting.

Training of new personnel.

Presented data reports on current projects.

Pliva, Inc., East Hanover, New Jersey 1/2006 - 7/2006

Associate Scientist

Involved in testing of solid dosage forms and HPLC troubleshooting.

Took part in notebook review and audits.

Performed assays, impurity analysis, content uniformity, dissolution, cleaning validations, blend uniformity, and pH meter calibrations.

Schering Plough Corporation, Union, New Jersey 4/2003 - 11/2005

Senior Chemist (contract)

Annually trained in cGMPs and 211 CFR. Involved in testing of liquid dosage forms (liquids, creams, topical solutions, and ointments).

Testing includes stability samples, finished products, complaint samples, process validation samples, and engineering studies.

Other responsibilities include investigation reporting, sample storage monitoring, training personnel, paperwork/data review, method transfer of Rebetol to European Market, and pH meter calibrations.

Participated in laboratory audits, trend analysis of products, and laboratory inspections.

Performed assays and impurity analysis (HPLC), swab sample analysis, and AA analysis.

Abbott Laboratories, Whippany, New Jersey 5/1999 - 4/2003

QC Chemist (Facility Closed)

Annually trained in cGMPs and 211 CFR.

Involved in testing of raw materials, in process samples, stability samples, and solid dosage forms, investigation reporting, control substance reconciliation, and pH meter calibrations.

Performed HPLC analysis, impurity analysis (HPLC and TLC), wet chemistry analysis, titrimetric and potentiometric titration, particle size analysis, cleaning validation, methods development, method transfer, method change, and content uniformity.

Alimenterics, Inc., Morris Plains, New Jersey 11/1998 - 3/1999

Analytical Chemist (Facility Closed)

Involved in testing of raw materials and stability samples, SOP writing, instrument and equipment validation, methods development, and methods validation.

Involved in the monitoring of sample storage for stability profiles.

Performed HPLC impurity analysis, melting point analysis, and wet chemistry analysis.

Wrote IQ/OQ/PQ for purified water systems.

Responsible for the monitoring and taking out samples for stability testing profiles.

Annually trained in cGMPs.

Novartis Pharmaceuticals, East Hanover, NJ 1/1996 - 11/1998

QA Chemist (Facility Relocated)

Involved in testing of raw materials and in process materials, control substance reconciliation, and supplier validation.

Performed wet chemistry analysis, HPLC and GC analysis, titrimetric and potentiometric titration, screen analysis, surface area analysis, TLC analysis, cold vapor AA and AA analysis, and water validation.

Annually trained in cGMPs and 211 CFR

Ortho Clinical Diagnostics/SmithKline Beecham – NJ 4/1994 – 12/1995

Analytical Chemist (contract)

Analysis of raw materials, in process materials, stability samples, and solid dosage forms.

Performed dissolution, content uniformity, HPLC and GC analysis, titrimetric titration, nitrogen analysis, and water validation.

Annually trained in cGMPs

Banner Pharmacaps-Elizabeth, New Jersey 10/1993 – 4/1994 Analytical Chemist(Facility Closed/Relocated)

Trained in cGMPs.

Involved in testing of raw materials and in process materials.

Performed wet chemistry analysis, titrimetric and potentiometric titration, cleaning validation, content uniformity, HPLC analysis, and AA analysis.

EDUCATION

BS, BIOLOGY, Rutgers University

OTHER EDUCATION

National Certification for Phlebotomist / EKG Technician, 1999 American School for Medical Profession

National Certification for Medical Laboratory Assistant, 1999 National Health Career Association



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