Project Management, Analytical Chemistry, Research and Development
Resume:
ATRI GUHA
Belleville NJ ***09
Phone (mobile) :( 973) - 519-1622
E-mail: ********@*****.***
Summary of skills:
Extensive experience in pharmaceutical industry as a scientist in Analytical Chemistry Laboratories. Expertise includes Method Development, Validation and Evaluation. Good presentation and writing skills for reports, proposed methods, and protocols for Method Development and Validation. Skilled in organic synthesis of small molecules. Extensively used Microwave technology in synthesis of molecules. Skilled in laboratory automation which includes instrumentation, data acquisition and processing. Experienced in project management and provided leadership in various projects.
Trained and supervised chemists in project related activities. Also experienced in different analytical techniques like Karl Fisher moisture analysis, UV, IR, etc.
Education:
1. Stevens Institute of Technology, Hoboken, NJ
M.S in Chemistry with concentration in Organic Chemistry
2. Calcutta University, Calcutta, India
B.Sc. with Honors in Chemistry
ACCOMPLISHMENTS:
1.Developed a size exclusion chromatographic method to separate two large molecules with the aid of an enzyme. Enabled the product to be launched successfully in the market within two months.
2.Developed an ion-pair chromatographic method to resolve a highly polar small molecule from its related substances, degradation products and impurities and permeation enhancers.
3.Developed a Normal phase chiral chromatographic method to resolve two stereo isomers of an API.
4.Separated four different related substances and two permeation enhancers of an anti-anxiolytic film formulation with a di-phenyl column and gradient elution. The robust stability indicating method facilitated the NDA for a quick approval by the FDA.
5.Designed special mass balance experiments to troubleshoot the root cause of stability failure for a pain management product. Led to the development of a new analytical method, which enabled the product to be re-launched, thereby saving the company from huge losses.
6.Developed a statistical model for Particle size distribution of Sodium carbonate in an antacid product, which enable the selection of correct particle size necessary for robustness of the product. The re-launched product reaped a profit of over fifty million.
7.Developed and validated analytical methods for identification, assay, and determination of impurities for a product for urinary incontinence within three months. The drug was approved by FDA and was a great success in market.
8.Developed a novel Dissolution method for a poorly soluble compound using surfactants and cyclodextrin. The dissolution method development made the product viable for FDA approval and future successful launch into the market.
PROFESSIONAL EXPERIENCES:
04 /2024 to Present
R&D Chemist Lupin Pharmaceuticals, Somerset, NJ
Responsibilities: Evaluation and Validation of Analytical methods, Stability studies, method validation of new products on development.
11/2022 to 04/2023: SGS, Fairfield, NJ, on contract basis for Actalent
Developed an assay and impurity HPLC method for a skin care product with an amino acid as API. Also performed method validation. Worked on formulations provided by the client. Modified and validated methods provided by the client. Tested client provided samples for stability.
06/2021 to 06/2022: Execupharm King of Prussia, PA
Scientist II Contractor at Merck & Co. Kenilworth, NJ.
Performed assay of Pre-formulation research samples by HPLC and UPLC. Used size exclusion chromatographic techniques and CAD to analyze large molecules ( proteins and peptides). Did basic mixing of active ingredients with solvents and excipients manually and autonomous Teacan process.
10/2019 to 04/2021: Zennova LLC. Orangeburg, NY
Senior R&D Scientist.
Develop and Validate analytical methods by HPLC for ophthalmic medications under development. Provided input regarding chemistry and quality of development process to the formulation group.
08/2018 to 07/2019: Pharmaceuticals International Inc., Hunt Valley, MD
Senior R&D Chemist.
Optimization and Evaluation of Analytical methods for-
a) Assay, Content and Blend Uniformity of solid and powdered dosages
b) Impurity of API, solid and powdered
c) Dissolution of solid and dosages.
06/2014 to 12/2017: MonoSol Rx, Warren, NJ
Scientist.
Develop Stability indicating Assay and Impurity HPLC methods of analysis for Oral and Buccal Soluble Films for Epileptic seizures, Gout and ADHD
Developed Dissolution methods for Thin Film dosages.
Provide Scientific Support and insights into new formulation development.
Develop Drug Dissolution methods for In vivo In vitro study
Lead Projects and supervise junior chemists and scientists
Write and review methods, reports and protocols.
Instruments used: HPLC, UV, FT-IR, Auto-Titrator, Dissolution Apparatus.
Products Handled: Different Pharmaceutical Thin Film formulations for the treatment of Epileptic seizures, Gout and ADHD.
02/2012 to 11/2013; G&W Laboratories., South Plainfield, NJ
Senior Scientist,
Developed stability indicating Assay and Impurity methods of analysis for Semi-solid and Liquid formulations by HPLC.
Developed methods for analysis of residual solvents and raw materials by GC
Led Projects and supervised junior chemists and scientists
Wrote and reviewed methods, reports and protocols
Reviewed analytical work and documentation of chemists.
Supervised and trained chemists on project related activities.
Products Handled: Creams, Lotions, and Ointments with APIs like Tazarotene, Desoximethasone, Betamethasone Dipropionate and Solutions/Injectable with Tolnaftate as API.
Instruments used: HPLC, UV, Auto-Titrator, FT-IR, GC.
09/2009 to 09/2011 Merck & Co., Summit, NJ
Senior Scientist (Contractor),
Developed Assay and Impurity methods of analysis for new Drug Substances and Formulations.
Developed Drug Dissolution Procedures and their Analytical Methods.
Wrote and reviewed methods and reports.
Reviewed scientific work and documentation of chemists.
Advised Scientists on technical aspects of projects.
Instruments used: HPLC, UV, Auto-Titrator, Dissolution Apparatus.
01/2008 to 06/2009 Actavis Pharmaceutical LLC, Totowa, NJ
Senior Chemist,
Developed and Validate HPLC and UV methods for API and solid dosages.
Wrote and reviewed methods, reports and protocols.
Lead projects pertaining to Analytical development.
Reviewed and evaluated Product technical packages.
Reviewed analytical work and documentation of chemists.
Supervised and trained chemists on project related activities.
Instruments used: HPLC, UV, Auto-Titrator, Dissolution Apparatus.
03/2006- 01/2008 BARR Laboratories, Northvale, NJ
Position: Chemist II
Performed Analytical Method Development and Validation.
Performed Accelerated Stability Study.
Wrote and Reviewed reports.
Projects Involved: Development of Assay, Related Substance and Dissolution methods of analysis of Pharmaceutical solid dosages and semi-solid dosages by HPLC and UV.
01/2002 to 03/2006. Glaxo SmithKline Plc. Parsippany, NJ.
Position: Scientist.
Performed Analytical Method Development and Validation.
Accelerated Stability Study.
Wrote and Reviewed reports.
Projects Involved: Analytical Method and Process Validation of OTC powdered dosages and tooth paste by HPLC.
Development of Analytical Method for analysis of Solid dosage product w/Vitamin D3 by HPLC.
Development of Size exclusion HPLC method for Assay of Methyl cellulose and its separation from protein.
Developed Particle size analysis model for Digestive formulation.
08/98 to 01/2002.KNOLL BASF Pharma. Whippany, NJ.
Position: Chemist.
Performed HPLC method and process validation of solid dosages .
Stability Study of Solid dosages.
Sustained release Dissolution by Zymate Robot.
Wrote and reviewed Reports and Protocols.
Products Handled: Various Pharmaceutical preparations of solid dosages for Hypertension, Pain killers.
03/98 to 08/98.NOVARTIS PHARMACEUTICALS: East Hanover, NJ.
Position: Analytical Chemist (On contract basis.)
Analyzed potency, impurities and degradation of anti-arthritic drug on stability by GC.
05/97 to 02/98. WYETH-AYERST PHARMACEUTICALS. Pearl River, NY.
Position: Analytical Chemist (On contract basis.)
Performed HPLC analytical method modification and validation of Water and Oil Soluble Vitamins and Injectable like Atenolol.
Wrote Analytical Project Reports and Protocols.
Developed Near-IR library for identification of Raw materials.
INSTRUMENTATION:
HPLC, UHPLC, UPLC (Agilent & Waters )
GC (PE, Agilent)
FT-IR (Nicolet) and Shimadzu
UV-VIS Spectrophotometers (Agilent, Shimadzu)
Laser Light Scattering Particle Size Analyzer (Sympatec)
Mass- Spectrometer: Thermo electron ESI.
Also knowledgeable of Polarimetry and Refractometer.
DATA ACQUISITION:
Empower 2.0& 3.0, Turbochrome 3.3 & 4.0, PE Applications, Beckman Peak Pro
Excel 5.0, and Waters Expertease.
LIST OF PUBLICATIONS:
1. Publication: Synthesis of Formylation products of Amines by Microwave Irradiation. Tetrahedron Letters.
2. Masters Course work: Synthesized b-Lactams from different Imines and acid chlorides. Bromination of b-Lactams using N-bromo Succinimide by microwave technology.
2a.Comparative study of Synthesis of b-Lactams by Microwave technology Vs traditional methods.
3. Publication pending:
1. Synthesis of Coumarin group of compounds by Microwave irradiation technology.
2. Synthesis of New Cage compounds by microwave technology.
3. Synthesis of acetylated products of hydroxy and di-hydroxy groups of aromatic compounds and study of their fragmentation patterns by Electro spray Ionization MS and GC-MS.
REFERENCE: On Request.
Contact this candidate