Manager Maintenance
Resume:
FELIX FREDERIC
Tamarac, Fl *****
Phone:754-***-****
Email: *****.********@*****.***
SUMMARY
A Scientist with a proven track record in the Pharmaceutical and Chemical
Industries. Experience in analytical chemistry, laboratory controls, and
biochemistry. Excellent knowledge of microbial, chemical, environmental,
and pharmaceutical analyses, as well as, good manufacturing practices.
Highly skilled in instrumental analysis: HPLC, GC GC/MS, ICP, UV-VIS, IR
and NMR. Ability to solve problems and to work in a team or individually,
in a fast paced environment.
PROFESSIONAL EXPERIENCE
CorePharma Corporation (Pharmaceutical Contract Manufacturing) 09/2011
- 02/2013
Chemist
* Performs analytical tests: Assay, Content and Blend Uniformity, Identity,
Impurities, testing of solid dosage finished product for release and
stability studies using HPLC, UV/VIS, KF titration etc.
* Interprets, documents, and reports test results within the scheduled time
interval.
* Ensures that all necessary corrections are executed in accordance with
cGMP standards.
* Notifies department supervisor/manager regarding omissions, incomplete
testing results or other irregularities.
* Conducts investigations in the areas of method performance and
reliability and evaluates proposed changes to compendia or developed
methods.
* Works within the laboratory in a team environment; assists with QC
initiatives; actively participates in QC projects and team meetings.
* Ensures that all laboratory notebooks, instruments logbooks and documents
are complete and in compliance with cGMP regulations and company
guidelines.
* Performs GC, HPLC and/or Wet chemistry analyses on Raw Material, In-
process and Finished Lot samples.
Provides quick turnaround of In-process samples to production.
HABA Division of Davion Inc. (Personal Products Contract Manufacturing)
09/2009 - 03/2010
QC Supervisor
* Utilized HPLC, Gas Chromatography (GC), and Atomic Absorption
Spectroscopy (AA) to analyze raw material, in-process and finished
product samples.
* Interfaced with production management for batch adjustments on OOS
manufactured bulk products and supported internal packaging and filling
requirements.
* Supervised/Coordinated stability studies and also executed stability
protocols.
* Authored: methods, stability protocols, stability reports, method
equivalency protocols and other technical documents.
* Developed and validated methods for analysis of medicated products.
* Reviewed validation documentation, including stability protocols, raw
data and summary reports for equipment qualification, process and
cleaning validation to ensure compliance.
LAB SUPPORT/STRYKER CORPORATION (Medical Devices) 03/2009 - 06/2009
Validation Specialist
* Prepared, wrote and reviewed Protocols and other related documents.
* Executed and reviewed test protocols for the validation of medical
devices.
* Reviewed current literature to ensure departmental compliance to
Corporate, Divisional and regulatory agency requirements.
* Assists in writing of SOPs, testing standards, protocols and reports
according to cGMP requirements and company guidelines.
* Assisted in investigations of OOS results; participated in self-
inspections and internal audits.
WYETH CORPORATION (Pharmaceutical), Pearl River, NY 06/2003 - 04/2008
QC Validation Scientist
* Performed (IOP) Q of various analytical instruments.
* Prepared analytical test procedures, documents and change controls.
* Performed calibration activities and execute validation protocols for
laboratory instrumentations according to maintenance schedules, SOPs and
cGMP requirements.
* Prepared, wrote and reviewed SOPs, Validation Master Plans/Protocols and
other related documents.
* Authored and reviewed Change Controls, Deviations/Investigations using
Trackwise and LIMS.
* Worked closely with Quality Assurance, Technical Services, Maintenance
and Engineering departments to ensure adequacy and appropriateness of
equipment function and proper documentation.
* Experience in Software Validation.
Developed and verified cleaning methods for vaccine process equipment.
Designed process development studies to support new manufacturing facility
start-up.
Developed TOC swab and rinse recoveries.
Wrote and executed protocols and delivered approved final reports.
LAB SUPPORT/NOVARTIS CORPORATION (Pharmaceutical) 10/2001 - 06/2003
Instrumentation Scientist
* Calibrated, installed, troubleshot, and repaired Dissolution Tester
(Various Sotax, Distek & VanKel dissolution equipment, HPLC, GC and
various analytical instruments.)
* In accordance with established GMP's, GLP's and SOP's, performed
dissolution test on solid dosage forms.(USP I and II)
* Evaluated and interpreted test data. Followed GMP and GLP regulations.
* Used analytical lab systems such as Blue Mountain to analyze and
interpret data for determining accurate calibration of instruments.
* Maintained appropriate documentation according to SOP's in following
cCGMP requirements and company guidelines.
SMITHKLINE BEECHAM, Parsippany, NJ 07/1999 - 05/2000
Analytical Chemist
* Conducted method validation to support product stability claims for
registration with worldwide regulatory agencies and quality control
release of varied oral care formulations.
* Reviewed stability data generated for correctness, for compliance with
GMP/GLP requirements, and for consistency with previously generated data.
* Performed HPLC testing of stability samples.
* Monitored status of stability equipment and chambers for completion of
calibrations, preventative maintenance and IQ/OQ/PQ requirements.
UNILEVER RESEARCH U.S. INC., Edgewater, NJ 04/1989 - 12/1998
Research Chemist
. Developed new cleaning technologies for laundry detergents to achieve
superior stain and soil removal.
* Assisted in the design of new bleaching techniques for stain removal
using air. This resulted in a patent application.
* Investigated the cleaning potential of new bleaching agents for household
detergent products resulting in improved product quality and cost
savings.
* Evaluate the viability of bleaching molecules by HPLC analysis.
* Proposed a mechanistic rationale for the reaction of novel bleaching
agents.
* Supervised and trained three research technicians. Planned, facilitated,
tracked and coordinated all research results.
SKILLS
Proficient at elucidation techniques such as HPLC, GC, UV-Vis, NMR, IR,
ICP, AA;
Proficient in Excel, Statistical Software, Waters Millennium 32, HP
ChemStation, PE TotalChrom,
Windows XP and associated applications
TRAINING
Course in Color Theory, Raritan, NJ
HPLC Course, Pearl River, NY
Surfactant Short Course, Norman, OK
Technical Writing Course, Edgewater, NJ
EDUCATION
BS, Chemistry, Jersey City State College, Jersey City, NJ, 1993
LANGUAGES
Fully conversant in French and proficient in Spanish
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