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Quality Control Manager

Location:
Chalfont, PA, 18914
Posted:
March 09, 2010

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Resume:

Analytical Chemist with ample experience on a variety of Chromatographic

and Spectroscopic techniques as well as traditional wet chemistry with

emphasis on purification, identification and structural elucidation of

pharmaceutical intermediates. Dedicated scientist with an open mind to

anything new or puzzling and able to work in a team with minimum

supervision on all stages of research from the design of the experiment,

through development, then to practical execution, including

troubleshooting, statistical data processing and results analysis.

Technical Skills

. Identification, purification and structural elucidation of small

molecules.

. Analytical and Preparative HPLC, LC-MS, UHPLC, GC-MS.

. NMR: 1 and 2D NMR, Homo and Heteronuclear experiments.

. MS: ESI, APCI, APPI, EI.

. FT-IR, KF, OR, CD.

. Laboratory automation: C++, Tcl, Perl, shell programming, SQL, Java.

. Software application: Chemstation, MassLynx, Analyst, Gilson, Xcalibur,

VNMR, Topspin, ACD

Professional Experience

Wyeth Research (acquired by Pfizer), Princeton, NJ

2006 - 2010

Research Scientist I

. Structural elucidation of pharmaceutical intermediates using Homo and

Heteronuclear 1 and 2D NMR experiments in conjunction with MS and FT-IR

data in order to help Medicinal Chemists to troubleshoot the reaction

conditions.

. Method development of a direct, sensitive, and selective method for

measuring changes in ?-alanine concentration in order to provide insight

into the role of ?-alanine in pain. This LC-APPI-MS method provided a

Limit of Detection of 0.005 uM and a Limit of Quantification of 0.02 uM.

. Set up and maintained new and existing LC-MS for Open Access Systems

maximizing the up-time of the instruments. Developed new fast LC-MS

methods for routine screening and specific methods for problematic

samples upon customer request.

. Designed and wrote a utility that automates the data handling for LC-HRMS

assays. This software reads the report data file generated by Mass

Hunter; processes and inserts data into the company data base; and,

generates and email PDF report files containing MS, HRMS and Analytical

HPLC data to the requesting scientist. This utility eliminated the

routine administrative tasks and the errors associated to them, allowing

the scientist to dedicate more time to research.

Johnson & Johnson Pharm. Research and Development, Spring House, PA

2005 - 2006

Co-op Student

. Demonstrated that the combination of CD/UV detection coupled with achiral

HPLC can be used for the direct determination of enantiomeric ratios,

increasing the throughput and robustness of the enantioselective analysis

of diastereomeric salts.

. Isolated a low level impurity (at 0.07% of drug substance) using at-

column dilution, mass-driven collection and comprehensive automation of

the entire process. This impurity was isolated with 91% purity allowing

it to be characterized by NMR analysis.

. Demonstrated how the Solid Phase Oxidation Reagents can be used in drug

stability/degradation studies to obtain general and selective oxidation

products with higher yields and faster reactions for isolation and

characterization purposes.

New Jersey Institute of Technology, Newark, NJ

2004 - 2006

Graduate Student

. Studied the stability of the P450 protein and the steric constrains that

arises when a modified heme prosthetic group is used in order to increase

the oxidative strength of the P450 protein for potential applications in

biocatalysis.

. Compared the tertiary structure of a protein against the folding

predicted by the Hydrophobic-Polar Protein Folding Model to determine the

quality of the model for predicting the folding of actual proteins.

E.N.S. N 30, Argentina

2000 - 2000

H.S. Chemistry Teacher

Quimica Lavalle, Argentina 1999

- 2000

Consultant

. Helped resolving quality, production, and efficiency problems.

I.C.P. SRL, Argentina 1995

- 1999

Partner and Production Manager

. Set up the manufacturing facility; including formulation and

manufacturing procedures, equipment and selection of raw materials and

packaging.

. Managed the production planning and scheduling.

Roby SA, Argentina 1991

- 1995

Quality Control Supervisor (1993 - 1995)

Lab. Technician (1991 - 1993)

. Improved, developed, and evaluated testing methods.

. Evaluated alternative raw materials: chemical/microbiological tests and

in-process behavior.

. Trained technicians in quality control techniques.

EDUCATION:

MS in Computational Biology, Jan. 2006

New Jersey Institute of Technology, Newark, NJ

Rutgers The State University of New Jersey, Newark, NJ

BS in Chemical Sciences, Apr. 1993

Universidad de Moron, Buenos Aires, Argentina

POSTERS:

Michael Breslav, Sergio Anis, Richard Dunphy, Brigitte Segmuller, Kelly

Swinney. Isolation of the Drug Substance Impurities at 0.05-0.1% Level

Using At-Column Dilution, Mass-Driven Collection and Comprehensive

Automation of the Entire Process. Eastern Analytical Symposium, Nov. 13-16,

2006, Somerset NJ.

Michael Breslav, Sergio Anis. Application of the CD/UV Detection

Combination with Achiral HPLC in the Preparative Separation or Enantiomers

by Selective Crystallization of Diasteromeric Salts. Eastern Analytical

Symposium, Nov 13-16, 2006, Somerset NJ.

RECOGNITIONS:

CSS Above and Beyond Award: Wyeth's Chemical and Screening Sciences award

for extraordinary contributions towards the departmental goals, due to my

work on the LC-MS Open Access Instruments. Dec. 6th, 2006

CSS Above and Beyond Award: Wyeth's Chemical and Screening Sciences award

for extraordinary contributions towards the departmental goals, due to my

contribution to automate data entry and report analytical results. Nov.

21st, 2007

PROFESSIONAL ASSOCIATIONS:

American Chemical Society, Webmaster for the Princeton Chapter of the

society.



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