FELIX FREDERIC

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

Tamarac, Fl *****

Phone:754-***-****

Email: acpfgn@r.postjobfree.com

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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