Manufacturing Project Management

DIVYALBEN PATEL

Cell: 201-***-**** **, St Paul’s Ave

Email: *************@*****.*** Jersey city, NJ-07306

OBJECTIVE: To excel as a professional in Pharmaceutical Quality and Manufacturing of Products.

EDUCATION: Stevens Institute of Technology, Hoboken, NJ, USA

Master of Science in Pharmaceutical Manufacturing (GPA 3.5) Dec 2011

Relevant coursework:

Good Manufacturing Practices (GMP) Validation and Regulatory Affairs

Bioprocess Tech in API Manufacturing Pharmaceutical Finishing & Packaging

Introduction to Pharmaceutical Manufacturing Introduction to Project Management

Contemporary Concepts of Pharma Validation Quality in Pharmaceutical Manufacturing

Academic Projects:

• Laboratory Instrument Qualification: Solving the Puzzle

Two terms of Qualification and Validation of instruments used by the pharmaceutical industry were researched.

• Validation & Qualification of Tablet (Cookie) Manufacturing

Developed a manufacturing process, qualified the equipments needed and made a complete validation package

• Prepared a Bid Package for Vial Depyrogenation Tunnel

Prepared User Requirement Specification (URS) and Equipment Purchase Specification, giving bid instruction to vendor, include vendor selection criteria and schedule bid review meeting.

Rajiv Gandhi University of Health Science, Bangalore, India

Bachelor of Pharmacy (GPA 3.89) Dec 2008

EXPERIENCE: Genzyme, Ridgefield, NJ Feb 2012-May 2012

• Perform analysis of drug substance, raw materials, stability samples using a variety of analytical techniques in support on cGMP production and process research.

• Stability testing studies for finished product

• Work with Enzyme-linked Immunosorbent Assay (ELISA)

INTERNSHIPS: Stevens Institute of Technology, Hoboken, NJ

Research Assistant Oct 2011-Nov 2011

• Reviewed and analyzed articles on TOC & helped in development of method validation.

Torrent Pharmaceuticals LTD, India

Summer Intern, Quality Control and Assurance Mar 2008-May 2008

• Studied the field of production (tablets, liquids and capsules) and maintained quality of products.

• Performed quality checks of finished products by HPLC, GC, IR and titrimetry.

• Prepared lab batches of solid and liquid products.

• Conducted stability testing, pH and viscosity tests on finished products.

Five Star Pharmaceuticals, India

Production Intern (Part Time Internship for B.Pharm) Jun 2007- Jul 2007

• Measured parameters during the production of tablets, capsules, and syrups and performed calculations based on the results.

SKILLS: Lab Skills: HPLC, Conductometer, Polari meter, pH meter, Dissolution and disintegration equipment, UV Spectroscopy, friability apparatus, TOC Analyzer etc.

Software: MS Office word, excel, PowerPoint, Minitab 15, MS-Project.

Other Skills: Written and explored research papers on cGMP Facility Design, Dry Granulation Processes, and Project Management skills, SOP reviews, and Analytical method transfers.

ACTIVITIES: Attended seminars on Interphex 2010 New York, Aerosol Technology, Volunteering

CERTIFICATION: Validation and Regulatory Affairs Graduate Certificate

Pharmaceutical Manufacturing Practices.

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