ASHISH CHA TTERJI

* ******** ****, **** *********, NJ, 08816 Tel:732-***-****

ac6kei@r.postjobfree.com

Employment Status-US Citizen

CARRER OBJECTIVE

Seeking a challenging position where the strong skills and experiences in formulation development, analytical and solid state characterization can be applied in drug product development of NCEs or generic drug molecules

EDUCATION

M.S. in Chemistry, 1990, University of

Bridgeport, CT

B.S. in Chemical Engineering, 1985 City University of New York, N.Y.

B.S, in Pharmacy, 1972 Jadavpur University, Calcutta, India ACCOMPLISHMENTS

● Applied novel hot melt extrusion technology to overcome the gelling behavior of the compound

● Developed alternate formulation for HCY -PI providing significant advantage with respect to patient compliance (smaller tablet size) and market acceptance

● Improved manufacturability for drug Product of BCS Class 2 compound with difficult milling behavior using novel formulation excipients

● Developed amorphous formulations of NCEs with immediate and controlled release PK profiles that enabled the team to fully evaluate the safety of the compound and helped make the decision

● Overcame the physical instability issues of IP Receptor Antagonist by utilizing a "non-aqueous" granulation" process to avoid polymorphic conversion during manufacturing, resulting in a stable tablet formulation.

●Served as a key member of departmental teams that: 1) Developed a formulation for Xenical, which demonstrated greater efficacy (48% fat excretion) at 60 mg dose. Compared to the market formulation (35% fat excretion) at 120 mg dose; 2) Identified the critical processing steps at the early phases of polymer microprecipitation technology for Cell Cycle Inhibitor (Ro 31-7453); 3)

.

● Developed new validated method for the particle size analysis of Accutane NF and Xeloda EXPERIENCE

May 2017 – Present : Principal Scientist, Liquid & Solid Dosage Formulation group, Novitium pharma, East Windsor, NJ

Responsibilities :

Develop oral liquid & solid dosage forms of generic & 505b2 formulation. ( such as Levocarnitine & Pyredostigmine Bromide solution, for 505b2 Indomethacin Capsule & Etravirine Tablet) January 2013- April 2017 : Principal Scientist, Solid Dosage Forms group, Kashiv Pharma, Bridgewater,NJ

Responsibilities :

● Develop oral dosage forms of generic drugs & 505b2 formulation. December 2007-December 2012: Principal Scientist, Solid Liquid Dosage Forms group, Pharmaceutical and Analytical R&D, Hoffman La-Roche Inc" Nutley, NJ Responsibilities:

• Develop oral dosage forms of new molecular entities having optimal stability, bioavailability and manufacturability for toxicology and clinical studies and ultimately for the market.

• Develop line extension oral dosage forms for marketed products.

• Prepare research directions and provide technical assistance in the manufacture of clinical supplies.

• Provide trouble-shooting with regard to formulation problems; identify and resolve critical steps in the manufacturing process.

Sept 2000-Dec 2007 Associate Principal Scientist, Solid & Liquid Dosage Forms group, Pharmaceutical and Analytical R&D, Hoffman La-Roche Inc" Nutley, NJ Responsibilities:

• Develop suitable formulations for safety studies with optimal exposure and the use of minimal excipients

• Develop oral dosage forms of new molecular entities and marketed products to improve their patient compliance and maximize their clinical benefit

• Provide research directions and the clinical team & assistance for the manufacture of clinical dosage supplies

• Provide trouble-shooting with regard to formulation problems; identify and resolve critical steps in the manufacturing process.

• Overcame the physical instability issues of IP Receptor Antagonist by utilizing a "non-aqueous" granulation" process to avoid polymorphic conversion during manufacturing, resulting in a stable tablet formulation.

Served as a key member of departmental teams that: I) Developed a formulation for Xenical, which demonstrated greater efficacy (48% fat excretion) at 60 mg dose, compared to the market formulation (35% fat excretion) at 120 mg dose; 2) Identified the critical processing steps at the early phases of polymer microprecipitation technology for Cell Cycle Inhibitor (Ro 31-7453); January1997 to August 2000: Senior Scientist, Solid Liquid Dosage Forms Group, Pharmaceutical and Analytical R&D, Hoffman La-Roche Inc, Nutley, N.J Responsibilities:

• Develop oral dosage forms of new molecular entities having optimal stability, bioavailability and manufacturability for toxicology and clinical studies, and ultimately for the market.

• Develop line extension oral dosage forms for marketed products.

• Prepare research directions and technical assistance in the manufacture of clinical supplies.

• Provide trouble-shooting with regard to formulation problems, identify and resolve critical steps in the manufacturing process.

• Had significant hands-on experience with processing equipment for oral dosage form development, effectively handled equipment-related problems.

January 1991- December 1996: Scientist, Solid State Characterization Group, Pharmaceutical and Analytical R&D, Hoffman-La Roche Inc, Nutley, NJ

Responsibilities:

• Physical characterization of bulk drugs and formulations.

• Use of thermal methods (DSC, TGAIFT-IR) and X-ray powder diffractrometry to determine the polymorphism of drugs.

• Use of BET instrument for surface area determination of drugs and excipients.

• Measurements of density by gas pycnometry.

• Measurements of refractive index of bulk drug substances using microscopic analysis.

• Measurement of micron size particles in parenteral and suspension formulations by Dynamic Light Scattering.

• Use of VTR instrument for moisture adsorption-desorption analysis of drugs and formulations

• Particle size analysis by laser diffraction and microscopic image analysis.

• Surface morphology evaluation by scanning electron microscopy.

• Method development and validation of particle size analysis for new drugs for NDA submissions.

• Validation of new equipment (e.g. Malvern laser diffraction instrument).

• Analysis of pharmaceutical raw materials by using various chromatographic spectroscopic and classical laboratory procedures.

• Develop testing procedures for raw materials using various chromatographic, spectroscopic and classical laboratory procedures.

• Perform various types of analysis including wet chemistry techniques, gas chromatography, thin layer chromatography, atomic absorption, UV-Visible spectrophotometry and high performance liquid chromatogrphy.

• Preparation of tentative specifications and directions for testing new raw materials for use by the Pharmaceutical Quality Control Department upon method transfer. Accomplishment : Gained experience and knowledge in the physical characterization of bulk drugs and formulations by using differential scanning calorimetry, thermogravimetric analysis/FT-IR,X-ray powder diffractrometry, scanning electron microscopy, image analysis, new methods of particle size analysis by laser diffraction and surface area measurement by BET, developed new validated method for the particle size analysis of acutane NF and Xeloda.

1978 - 1990: Group Leader, Quality Control Laboratory, Danbury Pharmaceutical Inc, Danbury, CT. Responsibility:

• Develop HPLC methods for new products for NDA submissions.

• Supervise 10 chemists performing analytical work (Dissolution, HPLC, UV-VIS, TLC, GC) for marketed products.

1972-1977 : work as a Tablet Dept. Supervisor at Sarabhi Chemical, India PUBLICATIONS (Author/C-author of several Patents, Publications and Roche internal reports (34)) PATENTS (filed)

1. Case Docket No. 25249 (Pharmasset Compound) filed in February 2009, PHARL\t1ACEUTICAL COMPOSITIONS FOR LOW BULK DENSITY DRUGS( A. Chatterji, N-25349 US ) 2. Case Docket No. 23288 (MEK Compound) filed In March 2007, PHARL'v1ACEUTICAL COMPOSITIONS FOR POORLY SOLUBLE DRUGS (.A. Chatterji, 051*******(N-I 026450). 3. US20070 184113 AI (Case Docket 22357) Pharmaceutical Composition Pharmaceutical Technologies for Improving the Manufacturability, Stability and Bioavailability of Poorly Soluble Therapeutics BOOK CHAPTER

I. Author of20 "Raw Materials-Specifications and Directions for Testing" RCR, Hoffman-La Roche, Nutley, NJ PRESENTATION I PUBLICATIONS

I. Implications of the level of Sodium Lauryl Sulphate when used as a Wetting Agent in a High Dose BCS Class IV Drug Product. A Aljaberi, A. Chatterji AAPS Annual Meeting" 2007 2. Effect of formulation and processing variables on the granulation kinetics of hot melt granulation (HMG) process, Sandhu-HK, ChaI1erji-A, et-al, Pharm-Dev-Technol (Pharmaceutical Development and Technology

(USA)); vol: 12, Pg: 145-151, Is: 2007,

3.Evaluation of the Solid State Properties of Solid Dispersions Prepared by Hot-Melt Extrusion and Solvent Co-precipitation methods -Addendum, Z. Dong, A. Chattelj i, AAPS Annual Meeting 2006 4. Effect of formulation and processing variables on the granulation kinetics of hot melt granulation (HMG) process, Sandhu-HK, Chatterji-A, et-al, Annual Meeting of American Association of Pharmaceutical Scientists, Baltimore, MD, 2005.

5. "Particle Size Characterization of Phytonadione Parenteral Colloidal Dispersion by Dynamic Light Scattering", manuscript for presentation at the 9th Annual Meeting of American Association of Pharmaceutical Scientists, San Diego, CA. November 6-10, 1994, OS/26/94. J. Lepore, A Chatterji (N-0135200). EOUIPMENT AND INSTRUMENTS Formulation: High shear granulator, fluid bed dryer, tablet press, film coater, extruder, spheronizer, comminuting mill, encapsulation, melt granulation, melt extrusion, spray drying, pellet coating, compaction simulator, flow evaluation, granule size analysis, amorphous processing by microprecipitated bulk powder, understanding of Process Analytical technologies (PAT), Quality by Design (QbD), Dissolution testing and In-vitro Invivo Relation (IVIVR). Ana1ytics: HPLC, TLC, GC, dissolution apparatus, DSC, TGAlFI-IR, dynamic light scattering, laser light scattering, Moisture sorption and desorption analysis, BET Analysis, UVNisible spectrophotometry, X-ray powder defractormetry, scanning electron microscopy, image analysis. AREAS OF RESEARCH INTEREST

• Drug Adsorption Improvement.

• Controlled Release Drug Delivery Systems.

• Powder, Tablet and Beadlet Technology.

PROFESSIONAL MEMBERSHIPS

American Chemical Society

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