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Quality Control Testing

Location:
Collegeville, PA, 19426
Salary:
Negotiable
Posted:
August 10, 2012

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Resume:

DAVID R. PELLETIER

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

Collegeville, PA 19426

610-***-****

********@*****.***

PROFESSIONAL SUMMARY

Analytical Chemist with 10 years of analytical chemistry experience in the pharmaceutical industry. Project management and analytical expertise in release and stability testing, method development/validation, method transfer and GMP data review. Instrumental analytical techniques, computer proficiency and literary skills including the following:

Separation: HPLC, GC, Size Exclusion Chromatography, Capillary Electrophoresis, IC

Spectroscopy: FTIR, UV/Vis, Proton and Carbon-13 NMR, LC-MS

Formulation Characterization: Dissolution, KF Titration, Hardness, Elegance (AQL)

Documents Authored: Certificates of Analysis, Clinical Release Memos, Analytical Methods, SOP's, Validation Reports, Stability Protocols

Computer Literacy: MS Word, Excel, PowerPoint, LIMS, Atlas, Empower, MIDAS,

Documentum, Electronic Laboratory Notebook, and ChemDraw

PROFESSIONAL EXPERIENCE

MERCK, SHARP & DOHME INC., West Point, PA (2002-present)

Analytical Chemist – Analytical Development and Commercialization (May 2007 – Present)

Member of a diverse analytical group supporting USP/EP/JP raw material testing, comparator release, late-stage clinical image release testing and cleaning validation. Performed assay, identity and dissolution testing of comparators and exact match placebos using USP reference standards or marketed products to release supplies. Coordinated analytical testing and directed the efforts of contractors to meet clinical timelines discussed with clinical supply colleagues.

Volunteered to support release, stability and method transfer testing of a reconstituted oral pediatric formulation to extend the patent of the adult formulation out to 6 months.

Participated in an improvement effort that prompted the creation of product specific expiry memos for manipulated comparator products in place of lot specific memos.

Converted comparator products, formerly released by memo, to electronic database (LIMS).

Research Chemist – Pharmaceutical Analytical Chemistry (October 2005 – May 2007)

Promoted to a project chemist role to aid the advancement of a pediatric chewable dosage form of a lead adult formulation. Provided in-process analytical support, stability indicating method development and final product clinical release analysis in accordance with cGMP's.

Established a shared stockroom for common supplies and reagents with a preferred vendor.

Maintained calibration/maintenance schedules of analytical equipment for the department.

Staff Chemist – Pharmaceutical Analysis and Control (December 2002 – October 2005)

Supported analytical testing of pre-clinical, clinical and stability samples of Merck development compounds from pre-phase I to phase III. Used Dissolution, HPLC and other physical and wet chemical testing to support IND and other regulatory filings. Provided results for in-process research and development of different formulated oral compressed tablets. Performed validation experiments and generated summarized reports for current analytical methods.

Directed the research efforts of a summer intern on the development of an accelerated solvent extractor method to analyze manufacturing materials and clinical packages.

Conducted analytical testing of a radio-labeled API in support of Phase II ADME testing.

GENAERA CORPORATION, Plymouth Meeting, PA (2000-2002)

Associate Scientist II

Created new products as potential mucoregulators via multi-step synthesis. Generated over 100 mucin inhibitory derivatives based upon a lead clinical compound. Used normal and reverse phase chromatography, preparative HPLC, and re-crystallization techniques to isolate chemical entities. Characterized compounds by performing and interpreting 1H and 13C NMR spectra.

CABOT CORPORATION, Billerica, MA (1995-2000)

Research Chemist

Synthesized molecules en route to carbon black surface attachment by diazonium chemistry. Performed surface modifications with various organic treating agents at both the lab and pilot scales. Tested carbon black-based inks for water and smear-fastness, inter-color bleed and optical density. Assisted manufacturing by testing physical properties of line samples during production runs. Managed and maintained a community processing equipment area.

Developed a new test to measure ink stability and stratification by accelerated aging.

Implemented a calibration program for shared equipment to support quality control.

Wrote, edited, and implemented SOPs and HAZOPs for new production equipment.

Mentored newly hired candidates and trained employees on safety and best practices.

EDUCATION

B.S. Chemistry, STONEHILL COLLEGE, North Easton, MA



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