Dhaval Patel

*** * ***** **, *******, NY ***** PH: 201-***-****

aceblg@r.postjobfree.com

Overview:

Pharmaceutical expertise with Master's degree in Pharmaceutical

Manufacturing and more than 3 years of hands on experience in US FDA

regulated Analytical method development and validation, Stability studies,

In-process and release studies, ANDA projects, analytical investigation

with trouble shooting, method transfer and analytical training.

SKILLS:

Software: Empower 3, Total Chrome, QuMas, MS Word, MS Excel and MS Power

Point

Instrumentation: HPLC, GC, TLC, UV Spectroscopy, Disintegration, USP

Dissolution Apparatus, Karl Fischer

Laboratory Proficiency: Expertise with assay, related compounds,

dissolution, content and blend uniformity, friability, hardness, PSD,

powder flow property, bulk/tap density,TLC, AA and pH studies; Force

degradation analysis; Lab scale manufacturing of tablet, suppositories,

cream and ointment; Qualitative and quantitative analysis of chemical

compound; Calibration of HPLC, Sonicator, pH meter.

Regulation: Experienced of cGMP, GLP, FDA and ICH guidelines

Personnel Skills: Excellent writing and communication, self-learner and

researcher, Self-initiative and motivated, timeline oriented, management of

team, strong knowledge of good documentation practice.

Certificates:

Bio-pharmaceutical Manufacturing, Project Engineering in Pharmaceutical

Manufacturing, Bioprocess Systems in Pharmaceutical Manufacturing

EXPERIENCE:

Norwich pharmaceuticals Inc. NY. USA Jan 2012- Present

Research Assistant (PDTS- R&D) and Lab Safety Officer

. Developed and validated analytical methods of pharmaceutical solid

dosage forms especially for assay, related compounds, content/ blend

uniformity, dissolution and identification.

. Performed tests like accuracy, linearity, solution stability, filter

compatibility, robustness, precision, Intermediate precision with

finished and synthetic drug product for CU, BU, Assay, Chiral purity,

Impurity/Degradation analysis of combination drug products as well as

individual entity.

. Performed accurate and timely analysis of release and pre-approved

stability samples.

. Theatrical and hands on experience in Force Degradation analysis.

. Exercised particle size distribution, bulk and tap density with powder

flow property for experimental and final batches.

. Performed technology transfer of analytical method between R&D and QC

department.

. Carried out dissolution analysis of Immediate, Controlled, Sustained

and Extended Release oral solid dosage forms, including dose dumping

and discriminating media studies with experience on App 1, 2, 7.

. Conduct routine analysis on HPLC-Waters and Agilent, Dissolution-

Distek, Karl-fisher titration and UV-Vis.

. Prepared and reviewed validation protocols, methods, stability tables,

data trending, certificate of analysis and final validation reports.

. Participated in trouble shooting of instruments and carry out

investigation analysis for OOS and OOT results.

. Recorded, evaluated, interpreted and summarized technical data

independently.

. Presented analytical data from internal and external sources, and

prepared reports for product release.

. Provided hands on training to coworkers and trainees regarding

Instrument operation and analytical testing.

. Independently manage products starting from experimental batches,

feasibility studies, protocol testing, release and stability testing

as well as participated for supervisory role in absence of group

leader.

. Participated in first to file projects with strict timeline and

successfully delivered product filling requirements.

. Arranged group meetings to develop project design, route cause

analysis and weekly reports.

. Initiated change control to method and procedures requiring

modification.

. Reviewed routine bench work, laboratory notebooks and logbooks.

. Voluntarily worked as Safety Officer for lab to make sure safety

compliance meets all the requirements to avoid any personnel and

property hazards.

. Observed safety rules and worked safely in the laboratory.

. Reported safety incidents and Multi Cause Analysis as a part of OSHA

requirement.

. Assisted in maintaining laboratory equipment, supplies and facilities.

Micron Technologies, PA. USA Aug 2011- Jan 2012

Process Operator

. Performed pharmaceutical micronization of APIs, Steroids, R&D

substances, Hormones and excipients using Jet Air Mill, Pin Mill, Loop

Mill, and Mechanical Mill.

. Generated and reviewed documentation BMRs followed by Client

instruction, cGMP and SOPs.

. Served as witness of routine unit operation tasks for batch record

signing.

. Participated in troubleshooting of micronization process and planed

production Schedule.

Shallby Hospital Pharmacy, India May 2009 -Jul 2009

Pharmacy Executive

. Lead the regional health campaign with 20 team members for diabetes

and High Blood Pressure awareness.

. Educated patients about patient compliance and apprise them of better

substitutes.

Shantam Pharmaceuticals Pvt. Ltd. Sep 2008 -May 2009

R&D Analyst

Learned and executed different aspects in tablet manufacturing including

granulation, compression, coating and packaging.

Executed analytical method validations of analytical method of Assay, BU,

CU and Dissolution of finished products.

Performed assay purity testing for APIs.

Participated in technical method transfer and training to Quality Control.

Managed whole laboratory for inventories and supplies of chemicals and

reagents.

EDUCATION:

Stevens Institute of Technology, NJ, USA GPA: 3.50

Master of Science in Pharmaceutical Manufacturing (May 2011)

Relevant course work:

. Introduction to Pharmaceutical Manufacturing and Project Management,

Good Manufacturing practice (GMP), Validation & Regulatory Affairs,

CAPA, Bioprocess technology and Bio Pharm Facility Design, Process

Analytical Technology (PAT), Quality in Pharmaceutical Manufacturing

and Design and Management of aseptic Pharmaceutical Manufacturing

Processes.

Rajiv Gandhi University of Health Sciences, India GPA: 3.97

Bachelor in Pharmacy (2008)

Relevant course work:

. Formulated and Analyzed pharmaceutical dosage forms. Gained knowledge

of Pharmaceutical Organic and Inorganic chemistry, Medicinal

Chemistry, Pharmaceutical Microbiology and Biotechnology, Applied

Biochemistry, Pharmacology.

REFERENCE: Available on request.

Contact this candidate