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Click here or scroll down to respond to this candidate Candidate's Name
Street Address PHONE NUMBER AVAILABLE
EMAIL AVAILABLE
SUMMARY OF QUALIFICATIONS
BS degree in Biology and Chemistry, with experience in R&D, Manufacturing
and QA in beverage/food science (8 yr.), Biotechnology/Biochemistry (5
yr.), Pharmaceutical (4 yr.), and clinical industries (3 yr.).
Extensive experience in training, managing projects and teams with time
sensitive deadlines.
Proven record of productivity enhancements through the application of lean
manufacturing, Operational Excellence, Eight Step Problem Solving and other
continuous improvements techniques.
Some experience with budget preparation and justification, travel plans and
organization.
Demonstrated success with implementation of international quality
management systems, including ISO 9K, ISO 14K, OHSAS 18K, ISO 17025 and
FSSC 22K. Intricate in ABBP becoming one of the first labs with ISO 17025
certified.
Advance experience with SAP, PICASSO, and Optiva formulation systems.
Knowledge in modern laboratory and manufacturing technologies used to
ensure purity and safety of products for human consumption.
Knowledge of GMP, GLP, and FDA regulations
Experienced in validation and documentation of tests, equipment and
processes supporting the introduction of novel beverage and pharmaceutical
products, including commercialization and clinical trials on new products.
Skilled in coaching, and interacting with multidisciplinary teams with
diverse cultural and professional backgrounds.
Years of experience as an elite volleyball coach, responsible with budget,
travel, organization of practices and tournament schedules.
PROFESSIONAL HISTORY
ALKERMES, Gainesville, GA Senior Analyst,
2014 - present
Responsible for using HPLC to determine the concentration and
identification of unknown samples solutions by comparing against known
standards.
Experience with writing and reviewing SOP's and training associates on
various laboratory techniques.
Qualified with using GC to determine the level of residual solvents that
may be present in a drug product after manufacturing process.
Skilled with the use of dissolution systems to determine the release
profile of a drug product over time.
Performing cGMP testing on stability samples of pharmaceutical time
released drugs.
Knowledge of the operation of HPLC's and GC's and experience using Empower
2 software
Extensive hands-on experience using a variety of laboratory equipment for
routine sample analyses (e.g., HPLC, UPLC, GC, UV-VIS Spectophotometer,
Dissolution Apparatuses, Karl Fisher titrator, etc.) in a regulated GMP/FDA
environment. ?
Reviews and approves laboratory data to ensure accuracy and completeness as
required.
Tests and analyzes raw materials, in-process samples and products to
determine stability, purity, chemical content and other characteristics.
THE COCA-COLA CO. (TCCC), Atlanta, GA Quality Assurance Analyst II,
2005 - 2013
Supervising and providing direction to Chemists in executing Quality
Control daily operations, and projects.
Supervise overall site Quality Control operations in compliance with all
applicable regulations and policies; including FDA, DEA, safety and
environmental.
Implemented Operational Excellence throughout the manufacturing facility.
PROFESSIONAL HISTORY (Cont'd) C. WEBB, Page 2
THE COCA-COLA CO. (TCCC), Atlanta, GA Quality Assurance Analyst II,
2005 - 2013
Ensure timely raw material, semi-finished, finished product, and treated
water system analysis on a daily basis
Evaluate ingredients, products or packaging materials via visual inspection
by measuring weight, density, stress, dimensions, torque, strength, etc. in
order to determine physical properties of samples and compliance with
standards.
Experience in setting up and running HPLC for all types of experiments.
(i.e. Size exclusion, ion exchange, reverse phase).
Use of GC to determine if ingredients and finished products meet company
specifications.
Perform chemical analyses using instrumental methods in order to determine
the composition of samples.
Discovered solutions for distressed and problem batches in order to
minimize losses.
Instrumental in the successful ISO 17025 accreditation for the laboratory.
Identify, conduct and lead opportunities to continuously improve quality,
cost and efficiency of processes.
Experienced with performing RCA and CAPA to determine process problems and
correct them.
Creates and revises specifications, SOPs and other appropriate documents
for QC operations.
Experience working in a manufacturing facility with tight deal lines and
cross-functional dependencies.
Accountable for the microbial and particulate monitoring of clean rooms
throughout the facility; including personnel monitoring of gowns and gloves
on a periodic basis.
Utilize proper testing as required for microbial identifications, bioburden
analysis, biological indicators, growth promotion, water, and sterility
groups. Responsible for reading microbial plates and interpret test
results.
Encompass Pharmaceuticals, Atlanta, GA Research Scientist
2004 - 2005
Used 7 step problem-solving process to determine and eliminate process
errors.
Providing project support for analytical activities in method transfer,
method development, and pre-formulation research.
Independent contributor to method validation of chromatographic-based
methods
Daily use of Quantitative Analysis, Data Reduction and Report Generation
and distribution to appropriate personal.
Method Development and validation of commercial and non-commercial products
for various vendors.
Team Lead for several projects with restricted time lines, which required
prioritizing tasks and resource allocation.
Worked closely with clients on validation of testing criteria for multiple
veterinarian medications, along with cost and timelines for completion.
Project leader of a team of 12 scientists, and engineers, tasked with the
responsibility to develop a novel transdermal formulation for proteins,
peptides, small molecules and vaccines.
Develop experimental formulations to support preclinical in vitro and in
vivo studies
Altea Therapeutics Tucker GA Research Scientist,
03/2004 - 09/2004
Project leader of a team of 12 scientists, and engineers, tasked with the
responsibility to develop a novel transdermal formulation for proteins,
peptides, small molecules and vaccines.
Assess viability of material choices for scale-up manufacturing.
Knowledge of excipients, drug vehicles and biomaterials, and experience in
characterizing formulations using HPLC, UV-Vis
Run SDS-PAGE and silver stain analysis for detecting insulin aggregation in
formulations
Analyze Hydromorphone in vitro samples by RP HPLC method as well as ELISA
Sample taking from hairless rats, for various ELISA and HPLC testing.
Physical property tests such as flash point, melting point, pH, Karl
Fischer, titrations, Brix, viscosity and salt conversions.
PROFESSIONAL HISTORY (Cont'd) C. WEBB, Page 3
Ciba Vision Corp. Duluth GA Research Scientist
2001 - 2004
Group leader responsible for the formulation of contact lenses using novel
technologies.
Developed QC/QA methods for reagents (e.g. GPC for Dextran, activity and
purity assays for Con A or other glucose binding proteins).
Developed various types of extremely sensitive immunoassays from scratch
(ELISA).
Trouble shooting immunoassays (i.e. High background and cross talk) to
improve sensitivity, while lowering sample volumes and increasing the
accuracy of results.
Attached dyes to proteins by their Amine group, and used FPLC to separate
the free dye from the conjugate by use of FTIR.
Knowledge of Universal Precautions with regard to the handling of
biological samples and biological waste.
Mirobiological testing of raw ingredients, semi-finished and finished
products.
Rhodia (Rhone-Poulenc) Inc. Winder, Ga. Research Chemist
1999 - 2001
BP Amoco Polymers, Alpharetta Ga. Research Chemist
1997 - 1999
INSTRUMENTATION: RELEVANT TRAINING
HPLC Pipetting Sligo Analyst Cert
GC Dilutions Microbiological
Cert
MS SPE SAP inspection
training
FPLC Wallac PICASSO training
AA Fluromax 3
NIR UV Vis
Titrator Fluorescent Confocal Microscope
Brix/Refract reader SDS Page
Balances Viscometer SELDI-MS
Micro Air Monitor FTIR Gel
Electrophoresis
Micro Plate Reader Dissolution Bath SELDI-MS
Incubators Bev-Screen Bio Safe Hood
Autoclave Depyrogenation Sensory
Evaluation
Spectrophotometer FIZZ Software Clean Room
UPLC Immunoassay ELISA Karl Fischer
Moisture Analyzer
EDUCATION: Francis Marion University BS Biology and
Chemistry
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