PRADIP PRAMANIK, PhD

*** ********** ******, ******, ** 08817 ( 973-***-**** (

acn1ji@r.postjobfree.com

SENIOR SCIENTIST, Analytical

. Developed, validated and transferred methods. Worked under FDA, ICH, EPA

and OSHA regulations and GLP/GMP.

. Worked on Small and Large molecules: Drug, Protein (antibodies and

enzymes), DNA, Oligonucleotide, Conjugates, Drug Metabolite and

Antibiotic.

. Used Chromatographic, Spectroscopic, Biochemical and Chemical techniques.

Solved analytical problems.

. Supervised scientists, technicians, students. Worked on collaborative

projects. Managed instrument center.

PROFESSIONAL EXPERIENCE

Analytical Scientist

Axcellerate Pharma (CRO,CMO),Aug-Dec, 2014: Developed Drug

formulation and HPLC methods.

*Enzon Pharmaceuticals, Inc., Piscataway, NJ. 2012-2013, Analytical R&D:

. Developed methods. Analyzed injectable formulations, 'Protein,

Peptide, LNA, metabolite and their PEG conjugates' utilizing

Chromatography, Light Scattering and Mass Spectrometry

techniques.

. Used HPLC (RP, IEC, SEC), SEC-MALS, MALDI-TOF MS, LC-MS and LC-

MS-MS (qtrap).

. Worked with CMO/CRO on transferred products and methods.

Monitored stability and performed release testing of drug

substances and drug products under GMP. Supervised others.

(Attended Biotech entrepreneur boot camp, BIO, explored starting a

business through STTR/SBIR, 2010-2)

*Enzon Pharmaceuticals, Inc., Piscataway, NJ. 2008-10 (ca. 2.5 yrs.),

Analytical R&D:

. Developed, validated and transferred (to CMO) GMP methods for

residual DNA quantitation (immuno-detection using ELISA and THS)

and SDS-PAGE (for separation and quantitation of protein

impurities) for protein drugs.

. Analyzed PEGylated Protein drugs to characterize degradation

products.

. Performed Forced Degradation Studies for protein drugs, for

regulatory submission. Analyzed samples from stability studies

under normal storage as well as stressed conditions.

. Collaborated with GMP CMO's, Partners and different departments

of Enzon during process optimization, scale-up and commercial

manufacture.

. Supervised others, 1-3 people, for method development and tech

transfer.

. Characterized protein and PEG-protein using HPLC, BCA and enzyme

activity assay.

. Wrote protocols (SOP's), validation reports and technology

transfer reports.

*Digestive Care, Inc., Bethlehem, PA, 2006-7 (ca.1.5 yr.). Analytical

R&D:

. Developed LC-MS, HPLC, GC-MS and Enzyme Assay methods for

characterization of enzyme/protein and non-protein (steroid)

drugs.

. Worked on Proteomics and Peptide Mapping. Characterized lipase,

esterase, amylase and protease enzymes using fluorescence assay

and other methods.

. Introduced chromatofocusing HPLC column before RP for analysis

of proteome.

. Analyzed enteric coated solid dosage formulations using

dissolution/hplc.

. Developed GC-MS and GC-FID methods for identification and

quantitation of residual solvents in drugs.

. Done validation, IQ, OQ, PQ. Trained others.

. Prepared reports for the CMC section of NDA for regulatory

submission to FDA.

PRADIP PRAMANIK, Page Two

ANALYTICAL CHEMIST:

*ICI / National Starch, Inc., NJ, 2005-6, ARD: Developed GC, GC-MS, LC-

MS, SFC methods, fulfilling FDA and

EPA specifications, for starch, fatty acids, protein, flavor,

fragrance, 'controlled release' analysis. *G. J. Chemical, Inc., NJ.

2004-5: QC/QA monitoring of compounds produced using GC, UV, IR, KF, RI,

etc.

under USP/NF, cGLP/cGMP. Made formulations. Trained a

technician.

*Tri-Seal, Inc., NJ, 2004: Set up headspace GC system and method for

QC/QA of Polaroid film production.

Wrote SOP and trained technicians.

*Environmental Industry, NJ, 2003-4: Used purge & trap GC-MS for

detection and identification of trace (ppb)

Organic compounds in soil and water under EPA, GLP, QA/QC

compliance.

Computer science student, pursued brain-mind-consciousness studies, 1997-

2003

Sr. BioAnalytical Scientist

Geo-centers, Inc. (contractor at the Naval Research Labs.), Washington,

D.C., 1993 to 1997, ARD:

R&D on Drug (of abuse) and Drug metabolites

. Developed immunoassay methods for detection of drug and drug

metabolites in human body fluids with ELISA.

. Synthesized drug-Protein (KLH) conjugates that were used as

immunogens.

. Generated antibodies (characterized with ELISA) against drug and

its metabolites, for use in the immunoassay.

. Characterized and studied structure of drug metabolites using HPLC,

LC, TLC, GC-MS, MS, 2D NMR, organic synthesis and biochemical

techniques.

. GC-MS was the primary tool, used most frequently. A multitude of

mass spectrometry (MS-MS, DIP, FAB, TS) and NMR (2D COSY and NOESY,

hetero COSY, COLOC, INADEQUATE) techniques were used for

identification of the drug and drug metabolite molecules.

. Wrote reports. Made presentations. Trained others.

Research Fellow, Biochemistry and Biophysics

The Johns Hopkins University, Baltimore, MD

Worked on Protein and DNA related to Cancer Research: Structure and

Repair of Damaged DNA

. Isolated, purified and characterized cloned DNA repairing enzymes

using HPLC, FPLC, LC, electrophoresis, biochemical assays,

fluorescence and CD.

. Worked on cloning mutants. Labeled plasmid DNA with tritium, for

use as enzyme substrate.

. Stabilized unstable enzyme. Developed fluorescence assay for

enzyme activity.

. Used 2D NMR for characterization of oligonucleotides to study

structural change in DNA during carcinogenesis and other processes.

EDUCATION

[MS student (Computer Science), 2001-2, George Mason University,

Fairfax, Virginia. gpa 3.9/4.0]

PhD (Physical Organic Chem., Studied structure & mechanism), The Ohio State

University, Columbus, Ohio.

TECHNIQUES USED

HPLC (normal phase, RPC, IEC, SEC, chromatofocusing, mals, elsd

UPLC, FPLC (with akta columns), 'Affi-gel, Phosphocellulose, Affinity'

column chromatography, Affinity column preparation (bonded ssDNA, substrate

for DNA repairing enzyme, to sepharose), TLC, SFC, GC (ECD, TCD, FID, NPD,

HD, headspace).

Dissolution (type 2 apparatus), Proteomics, Peptide Mapping using LC-

MS, Ultrafiltration, Dialysis, Antibody generation and characterization,

Enzyme assays (fluorescence, colorimetric and biochemical), ELISA, in vitro

DNA incision and cellular DNA repair assays, Gel electrophoresis and

autoradiography using 32P and 35S radioisotopes, SDS-PAGE, 3H labeling of

plasmid DNA, Cloning, cGMP, cGLP, IQ, OQ, PQ, 'FDA, OSHA and EPA'

regulations.

LC-MS (ESI, APCI), LC-MS-MS (qtrap), MS (DIP, FAB, TS, MALDI-TOF), GC-

MS (EI, CI), MALS, FT-IR, Fluorescence spectroscopy, CD (Circular

Dichroism), NMR (2D COSY and NOESY, hetero COSY, COLOC, INADEQUATE),

ChemStation, Empower, LIMS.

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