Injection Molding Project

Dipak .P. Patel

Address: *** ***** ****, **********, **-08854.

Phone: 908-***-****.

E-mail: *******@*****.***

ACADEMIC RECORD

Institution Date Degree Major Field

S.P. University 1996-1998 M.S Organic Chemistry

S.P. University 1992-1996 B.S Chemistry

PROFESSIONAL EXPERIENCE

NOVARTIS Pharmaceuticals

Scientist (Temp Position)

2009-2009

• Support formulation department to develop new drugs by analyzing drug on HPLC, IR, and UV.

• Method evaluation and method transfer of various drugs for solid and liquid drug products for

internal and external customers.

• Dissolution testing per USP criteria to perform the test on tablets and capsules.

• Support inhalation development department to develop new drugs by using NGI (Next Generation

Impactor) and analyzing drug on HPLC.

• Provides technical leadership in planning, monitoring, and maintaining project timelines to meet

business needs.

Catalent (Formerly Cardinal Health) Pharmaceuticals

Scientist

2004-2009

• Method evaluation and method transfer of various drugs for solid and liquid, gel capsules,

suppositories, lotions drug products for internal and external customers.

• Support formulation department to develop new drugs by analyzing drug on HPLC, IR, KF and UV.

• Dissolution (Apparatus I, II, III) testing as per USP criteria for Gel capsules, Capsules and tablets.

• Experience in laboratory investigations and documentation of OOS/OOT results (compliance- wire).

• Document check and review test results for soundness, accuracy and GLP/cGMP compliance.

• Investigated out of specification test results and prepared OOS reports.

• Supervise associate scientist. Write protocol and report for method validation.

• Assists in development of strategic plans for departmental goals. Understands and complies with

Safety, Company Affirmative Action, and Standard Operating Procedures and Policies.

• Establishing systems and procedures and supporting the analytical method development of solid,

liquid oral formulations.

• Responsible for setting up analytical laboratory as per lean six sigma program and kaizen event.

• Establishing systems and procedures and supporting the analytical method development, evaluation

of solid, liquid oral formulations.

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Able Laboratories Inc

Scientist

2003-2004

• Analysis of control drug in finished, stability and in process sample on HPLC systems using

Millenium32 and EMPOWER software. Work in team to release products and maintain record to

ensure compliance with FDA and CGMP regulations, Lab SOP and GLP in production sample.

• Calibration of pH meter, Dissolution apparatus, daily balances and HPLC.

• Hands on experience with wet chemical techniques and instrumental analysis, such as Karl Fisher,

Moisture analysis, Friability, GC, FT IR, UV and Disintegration.

• Dissolution testing per USP criteria to calibrate the equipments and perform the test on tablets and

capsules.

• Perform validation on various drugs.

• Conduct safety training.

Amide Laboratories Inc

QC Chemist

2002-2003

• Perform Validation on various drugs.

• Responsibility of QC testing of finished product, In-process sample and raw materials by USP, NF

and In-house methods on HPLC using TURBOCHROM and MILLENIUM 32 software.

• Perform Drug release of various products.

• Quality check of tablets for thickness, hardness, friability and color of coating. Ensure CGMP

Compliance in production and laboratory SOP and product release.

• Perform Validation on various drugs.

RESEARCH PROJECTS

• Worked on research project entitled “Synthesis, characterization and application of novel colored

epoxy resins." funded by UGC, Government of India.

• Worked for 6 months on research project entitled "Synthesis, characterization and application of

Benzothiadiazole moiety (As Agrochemical)" funded by Ocean Agro (I) LTD.

• Three years of academic experience in synthesis and development of organic compounds polymeric

compounds, characterization and analysis of organic compounds and resins etc.

• Familiar with techniques such as IR-spectroscopy, NMR-spectroscopy, UV-spectroscopy.

• Familiar with Injection Molding, Blow Molding, and Composite Forming etc. Familiar with

techniques such as TGA, Differential Scanning Calorimeter (DSC).

PUBLICATIONS/PRESENTATIONS

1. Study of curing kinetics and glass reinforced composites of novel triglycidyl epoxy resins.

Department of Chemistry, S.P University, Gujarat, India

2. Synthesis of acid dyes and their biodegradation study.

Department of Bioscience, S.P University, Gujarat, India

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