Quality Control Development
Resume:
Mt. Bethel, PA *****
************@*****.***
Profile A highly motivated, energetic and resourceful scientist with
extensive experience in analytical method development and
validation, packaging research, solid state characterization
in pharmaceutical industry. I am seeking a challenging
position where my knowledge and skills could be utilized
Skills & Hands on experience on various analytical and solid state
Abilities characterization techniques such as HPLC, GC, FTIR, mDSC,
UV/VIS, XRPD, Laser Diffraction (Malvern 2000), Dynamic
Light Scattering, ITC, microscopy
Extensive experience in packaging research, analysis of
leachable and extractable, moisture and oxygen permeability
testing
Hands on experience on characterization of tablet, capsule,
emulsion, suspension, liposome, nanoparticles, and amorphous
formulation
Good knowledge on GLP, cGMP, USP/NF testing and regulatory
compliance
Excellent computer skills with familiarity with Excel, Word,
Empower2, LIMS
Experience PRINCIPAL ASSOCIATE, Hoffmann-la Roche, nutley, nj
R&D, Preformulation Group; March, 2009 - August 31, 2013
Supported salt and polymorph screening studies for clinical
candidate selection and robust formulation development.
Measured particle size distribution of drug substance, in
process formulation and finished formulation employing laser
diffraction, light scattering, and image analyzer to support
milling and granulation studies.
Analyzed various toxicological and clinical formulations
using HPLC and ion chromatograph. Performed analytical
method validation, stability studies and assay of finished
product. Conducted dissolution testing on finished dosage
form.
Released pharmaceutical excipient according to USP/NF and BP
to support GLP tox and clinical manufactures.
R&D, Sterile Formulation Group; April 22, 2002 - March, 2009
.Analyzed and released in coming raw material, in process
sample and finished products under GLP/GMP and enter data
into LIMS on time
Developed and validated various analytical methods for
sterile product such as IV, SC and liposome formulations
Conducted packaging research to study leachable and
extractable from medical devices
Provided troubleshooting on particulates in IV products
using various microscopic and spectroscopic techniques
Transferred to PF group as a result of department closure
Achievements and Awards
Overturned a negative FDA packaging finding in only 21 days
to remedy a silicon tubing issue by developing a new
protocol and method to analyze the silicon tubing in house.
Overturned a negative FDA packing finding in only 21 days
for a styrene and ink packaging issue by developing a new
protocol and method to analyze the possibility of ink
leakage
Developed a protocol for an investigation of tablet
contamination(hairy material) with final drug product ;
Identified and remedied the source, enabling the product to
be released and protecting the company from an extraordinary
loss
Developed protocol for investigation of marketed tablet
coating issue - identified and remedied the source and
protected the company from litigation
Developing protocol for investigation of tablets
disintegrating in container with 2 desiccants - identified
and remedied the source, enabling the setting of new
stability conditions.
Scientist, Organon Inc, West Orange, nj
QC; Jan 20, 2002 - April 8, 2002
Performed a large variety of analytical tasks for the
analysis of drug products and raw materials
Prepared standards and samples for analysis and run
instrumentation independently including, but not limited to,
HPLC, GC, and dissolution
Scientist, bristoL myers squibb, new brunswick, nj
R&D; August 1, 2001 - January 10, 2002
Performed wet chemistry and chromatographic testing for
products under development phase, with most emphasis on HPLC
and dissolution testing.
Conducted wet chemistry and chromatographic analytical
method comparisons, analytical method verifications and
analytical method transfers.
Performed wet chemistry and chromatographic analytical
activities to support in-house formulation screening and
development.
Conducted associated stability studies and generate
stability reports.
Maintained proper laboratory notebooks and draft methods for
general laboratory procedures.
Performed other duties as assigned.
CONTRACT SCIENTIST, hoffmann-la roche, Nutley, nj
R&D, SOLID STATE CHARACTERIZATION; Jan 20, 2000 - July 15,
2001
Measured particle size distribution of drug substance, in
process formulation and finished formulation employing laser
diffraction, light scattering, and image analyzer to support
milling and granulation studies.
Analyzed various toxicological and clinical formulations
using HPLC and ion chromatograph. Performed analytical
method validation, stability studies and assay of finished
product. Conducted dissolution testing on finished dosage
form.
Released pharmaceutical excipient according to USP/NF and BP
to support GLP tox and clinical manufactures.
Scientist, chromak research, bound brook, nj
Analytical R&D; February 10, 1999 - Jan 10, 2000
Conducted comprehensive laboratory training courses, include
extensive hands on training in HPLC, GC, TLC, UV, IR,
Dissolution, standard laboratory equipment, GMP, GLP,
methods development, methods validation and troubleshooting.
lab technician, townley laboratories, north plainfield, nj
Environmental Lab; June 15, 1993 - January 24, 1999
Analyzed wastewater and sludge/solid samples for
microbiological and wet chemistry parameters.
Performed all quality control requirements associated with
the methods and maintain appropriate records
Prioritized work by creating schedules to complete daily
assignments
Interpreted and author SOPs, perform reagent formulation,
Record bench level observations, and keep records in bound.
Perform other duties as assigned and directed.
Education NEW JERSEY CITY UNIVERSITY, JERSEY CITY, NJ
MS in Health Science
NEW JERSEY CITY UNIVERSITY, JERSEY CITY, NJ
BS in Chemistry with Biology as minor
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