A ddress: **-B Flickinger Ct, Amherst, NY *****; Cell: 718-***-****;

E mail: abhunh@r.postjobfree.com Web: h ttp: / / w ww.linkedin.com / in / ddas2020

Debanjan (Deb) Das

Lead Product Development Scientist, CPL Niagara

Unique Skill: Well-rounded technical knowledge (encompassing chemistry, formulation, drug

delivery, process development, scale-up, tech t ransfer, manufacturing etc.) in driving a

p harmaceutical product from concept to commercialization.

P rofessional Summa ry

Formulation Experience:

• Over 8 years of hands-on experience in pre-formulation / formulation / re-formulation of

variety of dosage forms specializing in solids, semisolids & liquids for branded and generic (Rx

& O TC) products

• Formulated novel drug delivery systems utilizing nanotechnology (surface engineered

nanoparticles, nanoemulsions, liposomes) for targeted & sustained delivery of proteins,

peptides & poorly aqueous soluble compounds

• Designed, manufactured & packaged (cGMP) clinical t r ial materials in suitable

formulations (tablets, capsules, creams, ointments etc.) containing small molecules & biologics

Manufacturing, Scale-up & Support for Marketed Products (SMP) Experience:

• Strong background in addressing cGMP scale-up & process development issues while taking

p roducts from concept to commercialization (up to 3500 kg) including technology t ransfer,

validation, submission batches & other CMC related activities

• Well versed with cGMPS aspects of modern Quality Systems (QS) such as Corrective &

P reventive Action (CAPA), Discrepancy Investigation Reports (DIRs), Quality by Design

(QbD), Continuous Improvement etc.

Business Development & Project Management Experience:

• Provided scientific interface to potential clients/investors educating them to invest on newer

technology platforms for contract manufacturing & clinical t r ial materials

• Successfully managed projects for (cGMP) clinical t r ial & pilot scale manufacturing by

coordinating with formulation, production, QA, QC and clients/investors

Work Experience

Lead Product Development Scientist [ Contract Pharmaceuticals Limited (CPL) formerly

B ristol Myers-Squibb Pharmaceuticals, Buffalo, NY (2010 - cur rent)]

1 Das Debanjan-Resume

A ddress: 16-B Flickinger Ct, Amherst, NY 14228; Cell: 718-***-****;

E mail: abhunh@r.postjobfree.com Web: h ttp: / / w ww.linkedin.com / in / ddas2020

• Optimized process development parameters & t roubleshot low-yield & out of specification

(OOS) issues in large scale commercial batches up to 3500 kg including supporting

technology t ransfer to different manufacturing sites

• Successfully managed projects within a given t imeline for manufacturing & supply of cGMP

clinical t r ial materials & pilot scale batches by coordinating with QC, QA, production &

packaging

• Actively addressed to modern QS concepts by adding product knowledge & manufacturing

p rocesses in addressing DIRs, CAPAs plans, Change Controls, Quality by Design,

Continuous Improvement etc.

• Formulated & packaged novel creams, gels, emulsions, ointments, sprays, oral liquids,

suspensions for pre-clinical (R&D) & clinical t r ials (cGMP) containing small molecules &

b iologics

• Contributed to strategic business development by acting as a scientific interface in

customer relations

Formulation Scientist [Smithers Pharma LLC, Springborn Smithers Group, Wareham, MA

(2008 - 2010)]

• Formulated injectable liposomal (depot-based), micro & nanoparticulate based delivery

system for peptides and/or proteins including enhancement of solubility for poorly soluble

compounds by complexation, buffer adjustment, co-solvency etc.

• Re-formulated generic versions (Rx & OTC) of a branded products such as pediat ric alcohol-

free nasal decongestant, topical sprays, creams, lotions, ointments containing

corticosteroids, hormones, anti-inf lammatory, antibiotics, anti-cancers, anti-acne etc.

• Designed surface-engineered polymeric nanoparticles for oral peptide delivery & brain

t argeting & solved challenges of instability of peptide formulations in GI f luids &

macrophagic clearance of nanoparticles

• Pre-formulated a range of “drug-incorporation-ready” semisolid & liquid vehicles such as

emulsions, suspensions, gels, creams, ointments which can be utilized for rapid ini tial

formulation development for a range of small & large molecule drugs for early phase

development & clinical t r ials

• Actively involved in foundational steps of a specialized formulation services CRO with

f irsthand knowledge in managerial roles, scientific deliverables, client interface, project

management & associated business development

Scientist/Fellow [The Chao Center for Contract Manufacturing/ Dept. of I ndustrial

P harmacy, Purdue University, West Lafayette, I N (2005-2008)]

• Successfully developed solid dosage formulation (tablet) involving incorporation of an oily

d rug substance into a directly compressible g rade excipient, thus minimizing processing

s teps and overhead manufacturing costs

• Created SOPs for operation of machineries (tableting process by wet granulation) &

developed cGMP cleaning validation protocols for maintenance & qualification of production

clean rooms used for tableting & capsule filling

2

A ddress: 16-B Flickinger Ct, Amherst, NY 14228; Cell: 718-***-****;

E mail: abhunh@r.postjobfree.com Web: h ttp: / / w ww.linkedin.com / in / ddas2020

• Developed formulation & manufactured tablets by wet granulation technology & film-coated

t ablets by pan-pour & pan-spray method including t roubleshooting problems associated

w ith film coating of t ablets

• Evaluated degradation kinetics of solid dosage forms & optimized shelf-life by interpreting

k inetic data based on accelerated temperature, humidity, pH, oxidation & photolytic

degradations

• Optimized process development parameters in pilot scale cGMP manufacturing of an anti-

tubercular drug into tablets & capsules

I ntern [New Product Development, GlaxoSmithKline, I nnovation Center, Parsippany, NJ

(2005)]

• Reformulated an existing antacid tablet formulation improving product profile as compared

to i ts closest market competitor

• Optimized a product in development within the project deadline using statistical design of

experiments, thus minimizing the R&D effort while maximizing the knowledge gained for a

robust formulation

Project Manager [ Manufacturing Operations, Progressive Group, WB, I ndia (2001-2002)]

• Served as project manager in harmonizing batch manufacturing steps for pharmaceuticals

(Rx) & dietary supplements (OTC)

• Formulated an unique cost-cutting intermediary step for multi-use solid dosage form

manufacturing operation which required adoption of identical processing methods for

d ifferent products

I ntern [ Indian National D rug Co. Pvt. Ltd., WB, I ndia (2000)]

• Practical t raining in Tableting, Capsulation, Cream & Ointment manufacturing, QC

Quality Systems, Packaging & Filling Inst rumentations etc.

Education

Purdue University, West Lafayette, I N

• Master of Science, I ndustrial & Physical Pharmacy; Spring 2008

St. John's University, Jamaica, NY

• Master of Science, Pharmaceutical Sciences (Drug Delivery) ; Fall 2004

Rajiv Gandhi University of Health Sciences, Bangalore, I ndia

• Bachelor of Pharmacy (B. Pharm.), Spring 2001/ Pharm. D. Certification (FPGEC);

Spring 2004

3 Das Debanjan-Resume

A ddress: 16-B Flickinger Ct, Amherst, NY 14228; Cell: 718-***-****;

E mail: abhunh@r.postjobfree.com Web: h ttp: / / w ww.linkedin.com / in / ddas2020

Operational Skills

Softwares:

• Microsoft Office & statistical softwares such as Sigma Plot, StatMost, M ini tab (Six Sigma),

Design Expert (Design of Experiments) etc.

Analytical I nstruments:

• HPLC (Aglient & Waters), Particle Size & Zeta Potential Analyzer, UV-VIS-IR & Atomic

A bsorption Spectrophotometer, Fluorimeter, Scanning Electron M icroscope, Differential

Scanning Calorimeter, GC-MS, Polymer Membrane Electrodes, Lyophilizer, Rheometer,

Texture Analyzer etc.

Machineries:

• Experience in operating Pilot scale-up for semisolids (ESCO Lab & I KA BioReactor), Lee

Tanks & Koruma processing vessels (jacketed, vacuum operated - 100 to 300 gallons),

Tablet Press (Manesty), Capsule Filler (Zanazi), Granulator (Diosna high-shear

g ranulator), Coater (AccelaCota), Blender (Kinetics Tote System), Drying Ovens

(Gruenberg) etc.

Publications/Abstracts

• Debanjan Das, J.A. Augustine, M. Langenauer. Overcoming the Skin Bar r ier by Chemical

E nhancements - A Formulator’s Perspective. Transdermal magazine, Vol 2, No 2, 2010.

• Debanjan D as, N. K r illa, J.A. Augustine. Semisolid Formulation Development: the CRO

A pproach. White Paper. Pharmaceutical Technology. Sept 2, 2009.

• Debanjan Das, P. Couraud. Proton-Dependent Oligopeptide Transporter (POT)-Mediated

Uptake in the Novel Blood-Brain Bar rier Cell Line, hCMEC/D3. Abstract (2007). AAPS

A nnual Meeting, San Diego, CA.

• Debanjan Das, Shivakumar H.G, Gowda D.V, K r ishna R.S.M. Nanoparticles -

Neurotherapeutic agents through blood brain barriers. Indian Drugs, 42(11), 709-717, 2005

I SSN 0019-462X

• Debanjan Das, Lin S. 2005. Double-coated poly (butylcynanoacrylate) nanoparticulate

delivery systems for brain targeting of dalargin via oral administration. J Pharm Sci 94(6):

1343-1353

• Debanjan Das, Lin. Senshang. Nanovectors for Brain Delivery of Peptides by Oral

A dministration. Abstract (2004). AAPS Annual Meeting & Exposition, Baltimore, MD.

• Debanjan Das, Lin. Senshang. Double-Coated Poly (butylcyanoacrylate) Nanoparticulate

Delivery Systems for Brain Targeting of Dalargin via Oral Administration. Abstract,

GRASP 2004, 24th Annual Meeting, Mercer University, Atlanta, GA.

4

A ddress: 16-B Flickinger Ct, Amherst, NY 14228; Cell: 718-***-****;

E mail: abhunh@r.postjobfree.com Web: h ttp: / / w ww.linkedin.com / in / ddas2020

Re ferences: Available upon request

5 Das Debanjan-Resume

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