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Nila Das Email: nd8b8712@westpost.net Tel# 646.595.

6422

Summary
Experienced pharmaceutical product development manager with extensive knowledge
in formulation development, characterization, scale-up and manufacturing of conv
entional (tablets, parenterals and topicals) and controlled release dosage forms
(microspheres, nanoparticles, coated dosage forms, bioadhesive biodegradable po
lymers and mucoadhesive delivery systems).
Accomplishments include:
* Filed 2 INDS (with US FDA) for small molecules, exhibiting excellent extended
plasma-concentration versus time profiles.
* Filed NDA (with US FDA) on protein based parenterals with improved pharmacokin
etic-pharmacodynamic profiles (PKPD profiles) than currently available therapies
. Designed and prepared laboratory batches, optimization studies (using DOE), s
cale-up, validation batches, registration batches and extensive regulatory docum
ents.
* Lead and manage a multidisciplinary team to develop and optimize oral mucoadhe
sive delivery systems including extended release tablets, gels and patches, and,
injectables and topicals. The team includes members from formulation developme
nt, analytical characterization, project management, device department, technica
l transfer, scale-up, and business development.
Experience
Product Development Mgr Biodel Inc in CT (Nov 2007 - Present
)
* Develop, conduct, and coordinate novel drug delivery research and dosage form
design under cGMP controlled environment, provide guidance to junior scientific
staff.
* Developed oral rapidly dissolving and oral controlled extended release tablets
using HPMC, mannitol, Carbopol by direct compression and wet granulation techno
logies. Resolved problems related to release profile, segregation issues, disint
egration time and mouth feel through judicious selection of excipients. Related
performed studies include development of generic products, hardness, friability
, weight variation, content uniformity, LOD, tap density, bulk density, disinteg
ration and dissolution testings.
* Lead parenteral and topical drug delivery projects - Reformulate existing comm
ercial products (generic) to achieve longer shelf-life and improved PKPD profile
s. Formulated protein and small molecule parenteral products with improved stabi
lity, immediate and sustained plasma-concentration time profiles, optimum osmola
lity and pH. Specific studies include solubility, stability (ICH routine, interm
ediate and accelerated), effect of pH and zeta potential, excipient compatibilit
y, reverse-engineering of commercials products using filters, development of lyo
philized products, formulation-container compatibility, container-closure integr
ity, in-vitro release studies, permeation studies, mucoadhesion, swelling and /
erosion and physicochemical characterizations of developed formulations.
* Developed oral extended release mucoadhesive delivery systems (bi-layered tabl
ets, Pluronic and Carbopol gels and patches) for small molecules and proteins ha
ving potential to act as extended release depot systems via alternative routes o
f administration such as buccal, ocular and nasal amongst others.
* Apply DOE in formulation development, use statistical tools such as ANOVA, t-t
est, regression analysis in data interpretation.
* Write extensive scientific reports for regulatory submissions (IND, NDA and 51
0K, 505(b)(2)).
* Manage manufacture of batches in coordination with QC and Regulatory departmen
ts, contact vendors for chemicals, coordinate with CROs for outsourced analytica
l works, work with CMOs and CROs to oversee technology transfer and outsourcing
work.
* Develop protocols for research, stability studies and for validations of analy
tical methods, SOPs for equipments, test methods and manufacturing processes.
* Coordinate with analytical scientists and Quality Control Department to comple
te testing of finished products in a timely manner.
* Review batch records and QC data.

Doctoral Fellow Saint John's University (2002-07)


* Formulated mucoadhesive semi-solid gels for buccal delivery of peptides: Studi
es involved Pluronic F127 gel preparation using DOE, preformulation studies, phy
sico-chemical characterizations, determination of release profile, permeation st
udies and in-vivo animal studies etc.
* Used Fusion Pro software (Smatrix Corp) to screen and optimize insulin loaded
gel formulations for administration on animals. Derived multiple regression equa
tions, Pareto's charts to illustrate the effect of formulation variables on resp
onse parameters.
* Conducted in-vivo buccal and subcutaneous experiments on rats, analyzed pharma
cokinetic parameters with WinNonlin software (Pharsight(R)) and statistical test
s (ANOVA, t-test).
Manufacture of Solid Dosage Forms Saint John's University (2002)
* Investigated process variables of tablet manufacturing using wet granulation t
echnology.
* Prepared small laboratory batches of coated tablets using various diluents, di
sintegrants, binders, lubricants and coating agents in different concentrations.
* Resolved problems associated with film coating of tablets.

Bioanalytical method validation Saint John's University (2002)


* Case studies on FDA regulations, Warning letters (483s) and ways to avoid them
.
* Studied Manufacturing & operational principles related to pharmaceutical indus
try.

Liquid Oral Formulation Development Saint John's University (2003)


* Reverse engineered branded expectorants in product formulation course.
* Addressed problems of drug solubility using co-solvents, pH modulation.
* Optimized excipient compatibility by modifying order of mixing.
* Resolved stability issues through appropriate use of preservatives.
* Obtained desired pH using suitable buffers.
* Scaled up the prepared dosage form.

Masters Research (in Pharmaceutics) Jadavpur University (1999-2001)


Formulated microspheres of diclofenac sodium for oral drug delivery: Studies inv
olved microsphere preparation, physico-chemical characterization, release profil
e determination etc.
R&D Scientist, Dey's Medical, Calcutta (Sep 99-Dec 99)
Apprenticed in Tablet / Capsule manufacture, Oral liquids, Ointment, QC & Packag
ing departments.

Instrument Proficiency
* Particle Size / Zeta Potential Analyzer
* Lyophilizer
* HPLC
* Differential Scanning Calorimeter
* ELISA
* UV-VIS-IR Spectrophotometer
* Atomic Absorption Spectrophotometer
* Fluorimeter
* TGA
* Scanning Electron Microscope
* Microscopy
* LC-MS

Education
PhD, Pharmaceutics / Industrial Pharmacy/ (2008), Saint John's University, New Y
ork (GPA 3.7/4.00)
Doctoral Dissertation: Formulation development and evaluation of Insulin loaded
Pluronic gels for Buccal drug delivery
Master of Science, Pharmaceutics, Jadavpur University, India (2001): Stood 1st i
n the University.
MS Dissertation: Formulation development and evaluation of Diclofenac Sodium loa
ded microspheres for oral drug delivery
Bachelor of Pharmacy, Jadavpur University, India (1999): 1st Class.

Graduate Courses at SJU (47 credits)


* Instrumental Methods of Analysis
* Industrial Pharmacy
* Degradation & Stability of Pharmaceutical Systems
* Product Formulation
* Biostatistics
* Homogenous & Heterogeneous Pharmaceutical Systems
* Pharmaceutical Materials
* Special Delivery Systems
* Ocular Delivery Systems
* Biostatistics. Principles of Manufacturing Pharmacy
* Advanced Biopharmaceutics
* Biotechnological Delivery Systems
* Principles of Experimental Design
Computer Proficiency/Statistical Software
* Fusion Pro
* Microsoft Project Management
* WinNonlin
* Empower
* Sigma Plot
* Microsoft Excel

Publication / Abstract / Awards


* N. Das, P. Madan and S. Lin; Development and in vitro evaluation of insulin-lo
aded buccal Pluronic F-127 gels, Pharmaceutical Development and Technology Apr 2
010, Vol. 15, No. 2: 192-208.
* N. Das, P. Madan and S. Lin; Statistical optimization of insulin-loaded buccal
Pluronic F-127 gels, Accepted for publication in Pharmaceutical Development and
Technology.
* GATE-Graduate Aptitude Test for Engineering (score 97.3 percentile) in 1999 fo
r postgraduate studies in pharmaceutical sciences.
* Hazardous Waste Generator Training in 2008
* Member of AAPS, CRS and Rho Chi Pharmacy Honor Society.