9, Pondview dr, Apt# 2 PHONE: (551)-208-8025

East Patchogue, NY 11772 E-MAIL:ap803d30@westpost.net

Amit Shankarbhai Patel

A Resourceful Scientist with more than three years of experience in the field of
formulation development in a generic pharmaceutical. A Skilled troubleshooter w
ith strong organized and professional communication skills.

SUMMARY OF SKILLS AND QUALITIES

Ability to handle product development from preformulation to Scaling up levels i
n a very cost effective system.
Formulation Development of controlled and immediate release dosage forms.
Experience in leading technology transfer , scale up batches , exhibit batches f
or clinical trials.
Technical Leadership with successful scientific and instrumental troubleshooting
skills
Effective Technical Writing skill
Knowledge of IPR and patent interpretations.
Experience as troubleshooter of analytical problems and related issues.
Experience to help and facilitate product development with co-ordination to meth
od development
Working ability with hazardous, Toxic, flammable, Hormonal, cyto-toxic materials
.
Experience of working in group with successful management of resources.
Ability to handle small experiments without any resources.
PROFESSIONAL EXPERIENCE
Amneal Pharmaceuticals LLC, NY, USA March 2007 - Till Date
Formulation scientist
Hands on experience to operate and troubleshoot various analytical instruments l
ike: dissolution apparatus, Infrared spectrophotometer, UV spectrophotometer, Ga
s chromatography and HPLC
Raw material characterization and evaluation according to USP monograph.
Reviewing and concluding analytical reports
Preparation of reports of analytical data in graphical and easily understandable
comparative formats
Preformulation studies including characterization of API solubility, polymorphis
m, particle size analysis and excipients compatibility studies.
Characterization and screening of excipients on the basis of desired performance
of the dosage forms.
Experience in development of various immediate release Solid dosage forms, contr
olled release tablets, delayed release capsules.
Fundamental knowledge of functional coatings and sphere coatings.
Specialization in hormonal drug projects and potent compounds ( cyto-toxic drugs
)
Speciality in handling materials and processes in confined work environments.
Patent analysis and submitting the reports for patent study
Patent review and development of the strategy for patent non infringing formulat
ions.
Formulation and development of Paragraph III and Paragraph IV products for the o
rganization.
Deciding the discriminatory and biorelevant dissolution media.
Formulation Development in systematic manner by conducting preformulation and st
ability studies according to ICH guidelines.
Development and validation of Pilot scale processes
Preparation of Critical Process Summary Reports
Scale-up of pilot scale processes to production scale processes.
Provided technical assistance and troubleshooting for product development relate
d problems.
HANDS ON EXPERIENCE TO OPERATE:-
Tablet Presses (Single and double layer) Cadmach , sejong , killian.
Fluid Bed Processer/Coater (Glatt, NIRO)
Automatic Capsule filling machine (Sejong, PAM), manual hand filling capsule mac
hines.
Rapid Mixer Granulator, Planetory mixers.
Coating machines ( Accelacota , Glatt, SSPM , Conventional coating pans )
Comminuting Mill( clitt mill) Comill
Blenders ( V-Blender, Bin blenders )
Roller Compactor (Cadmach)
ACADEMIC PROFILE
B.Pharm Passed in May 2005, from A.R.college of pharmacy, Saradar
. Patel University, Vallabh Vidya nagar, Gujarat.

M. S Passed in year 2007 with specialization in chemi

stry with concentration in pharmaceutical chemistry from Fairleigh Dickinson Uni
versity, Teaneck, New Jersey, USA

PERSONAL DETAILS

Marital status : Married

Work Status for US: H1B Visa till 10/2011

Current Compansation: USD 45,000/ year + incentives