Sandip Shah

**** ******* *****, # ***, ********, VA 20110

Contact: 201-***-**** Email: ablhbk@r.postjobfree.com

Summary:

• Securing position in the esteemed organization where I can utilize my innovative ideas, progressive experience for

accomplishing the projects in the field of biotech.

• Strong work ethic and sound scientific background with strong analytical and problem solving skills.

• Working knowledge of cGMP, GLP guidelines, OSHA standards and experience of applicability of CAPA (Corrective

Actions and Preventive Actions).

• Performing formulation of Media, Buffers, Salt solution, Cell culture reagents, and Bio molecular products.

Skills:

• Laboratory: Electro-chemical titration, Chromatography, Colorimetric technique, Karl Fisher technique, Analysis of

different chemical compounds, Microbiological assay, Dissolution test, Distillation and Conductometric technique.

• Equipment: HPLC, GC, Tablet compression machine, Granulator, Mixer, Bioreactor, and pH meter, Osmometer,

Conductivity meter, and Kaye Validator 2000.

• Computer: Microsoft Suite (Word, Excel, PowerPoint, Project), and Internet applications.

Employment History:

Mediatech Inc. Manassas, VA Present 07’2010

Formulator

• Performing CIP(Clean In Place) and SIP( Steam In Place) on the process equipments like Tanks, Filtration lines and

Filling lines.

• Formulating Media, Buffer salt solution, Cell culture reagents, and Molecular biology products like Antibiotics, and

Antimycotics as per SOP’s.

• Experience with calibration of temperature, pressure, flow, pH, and conductivity instrumentations.

• Executed daily tasks including sampling and monitoring the formulation water for Endotoxin and TOC (Total Organic

carbon).

• Actively involved in documentation work as per cGMP

Lincoln Pharmaceuticals LTD. Ahmedabad, INDIA Sept 06 - July 07

Quality control Lab Associate

• Performed process manufacturing tasks including operation of small and large scale equipment, weighing, measuring,

monitoring of raw and inprocess materials to assure batches contained proper quantities and process output.

• Reviewed and revised of documents such as validation reports, analytical procedure and SOP’s.

• Experienced with preparation of mammalian cell culture and sampling operation in aseptic media.

Internship:

Dishman Pharmaceutical & Chemicals LTD. Ahmedabad, INDIA Nov 05 - Jan 06

• Received training in process tasks, scientific theory and process documentation in order to become qualified

under cGMP guidelines to perform generic API pharmaceutical manufacturing tasks.

• Underwent technical training in various process operations like aseptic filling operations, lyophilization with

isolator technology, labeling and packaging of filled vials as per GMP’s.

Education:

Master of Science in Pharmaceutical Manufacturing, Stevens Institute of Technology, NJ GPA 3.57/4.0 May’10

Coursework: Validation and Regulatory Affairs in Pharmaceutical Manufacturing, Project Management, Pharmaceutical

Finishing & Packaging, Bioprocess Technology in Pharmaceutical Manufacturing, Good Manufacturing Practice (GMP) in

Pharmaceutical Facilities Design, Design & Management of Sterile Pharmaceutical Manufacturing.

Bachelor of Science in Pharmacy, Rajiv Gandhi University of Health Sciences, India GPA 3.6/4.00 Sep’06

Coursework: Pharmaceutical Chemistry & Applied Biochemistry, Pharmacology, Industrial Pharmacy, Pharmaceutical

Microbiology.

Projects:

• Automation in recent cell culture technology and sensors used in biopharmaceutical industries.

• FDA’s current regulatory affairs: - Application of Six Sigma, PAT(Process Analytical Technology), and Qbd(Quality

by Design) in the pharmaceutical Industry.

References Furnished Upon Request

References Furnished Upon Request

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