NIKHIL S DESAI

*** ****** ******

Jersey City, NJ 07307

i18rfa@r.postjobfree.com

Cell: 201-***-****

Objective: Seeking an opportunity to work in a Pharmaceutical manufacturing unit/lab to reinforce theoretical knowledge acquired and to hone the practical skills.

Education: Master of Science in Pharmaceutical Manufacturing Engineering, Dec 2009 - GPA: 3.37

Stevens Institute of Technology, Hoboken, NJ

Bachelor of Pharmacy, 2007 - GPA: 3.67

PES Collage of Pharmacy, Rajiv Gandhi University of Health Science, Banglore, India

Major Courses: Good Manufacturing Practice (GMP) in Pharmaceutical Facilities Design, Validation and Regulatory Affairs in Pharmaceutical Manufacturing, Introduction to Project Management, Bioprocess Technology in Pharmaceutical Manufacturing, Pharmaceutical Finishing & Packaging Systems-Solid Dosage, Design & Management of Sterile Pharmaceutical Manufacturing and Biopharmaceutical Facility, Contemporary Concept Pharm Validation.

Presentations & Research Papers -

• Presented Project paper on Designing of Sterile Fluid Manufacturing Unit; 11/08

• Presented Research paper on Disposable technology; 11/08

• Preparation of Validation Master Plan for Freeze Drying Process using Lyophilizers.

• Presented research paper on project management & cost estimation for new facility development. 05/09

• Project to develop Process Validation and Quality Assurance of Chocolate Chip cookie to launch in a new Zone due to increased Demand. 11/09

• Presented seminars on Manufacturing Process of Cold cream and Vanishing cream.

Skills & Strength: Organizing, Planning and Management of Team Projects

 Have Perseverance at the Time of Frustration and be a diligent problem solver.

 Good Understanding of GxP (CGMP, GLP, GDP) Standards, 21 CFR Part 11: Electronic Records and Signatures, 21 CFR part 210 and 211

 Knowledge of Process and Equipment FMEA’S, PFD’S, SOP’s, Validation IQ/OQ/PQ Protocols, Swab Sampling as one of the Cleaning Validation Procedure.

 Performed drug efficacy testing on laboratory animals like mouse, rat and guinea pig.

Technical: Lab Skills: Performed blood, urine and chromatography tests- HPLC, TLC, Analysis of Different Chemical Compounds, Titrations, Preparation of Chemical Solutions, UV Spectroscopy, Microbiological Assays, Identification and Tests of Organic and Inorganic Compounds, Determination the Effects of Drugs on Animals, dissolution and disintegration testing of solid dosage forms.

* Experiment on bench with raw materials, emulsification systems, processing techniques and formulations in traditional, and/or non-conventional creative approaches.

Experience: Meridian Enterprises Pvt. Ltd, India -May 2005 - June 2005 & Jan 2007 - June 2007

• Observed and operated in quality control, production and packaging department.

• Perform In-process quality and raw material testing.

• Performed tests to ensure Quality Control & Quality Assurance in Laboratory.

Student Assistantship Program Nov- 2004

• Helped professor in gathering data from internet and in laboratory work

Computer: Advanced proficiency in MS Office, MS project, Minitab 15

Activities: Member of ISPE since April’08, Cricket, bowling, table tennis, Badminton

Reference: Available upon request.

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