Engineering Content

kartikeya bahl

Email: *********.****@*****.***, Phone :310-***-****, Apartment 2102, 41 Tyler avenue, New Jersey, 08330

Education

MS Biomedical Engineering Inter Departmental Program (2007 2008 ) University of California Los Angeles

Area of specialization : Cellular and Molecular Bioengineering GPA: 3.36

Regulatory Affairs Certification (in progress) Regulatory Affairs Professional Society

BE Biotechnology Engineering (2003 2007) University Institute of Engineering & Technology, Panjab University,

Chandigarh, India . Percentage : 67.04

INDUSTRY EXPERIENCE

OHM LABORATORIES INC New Jersey(2008 Present)

Area of specialization: Analytical Chemist in the QC Lab (ANDA, Finished Products Department)

• Handling of Cleaning Verification, Cleaning Validation, Method Validation, Process Validation and Impurity Profile

studies in the company using HPLC, UPLC, UV Vis Spectrophotometer and Gas Liquid Chromatography.

• Managing stability programs and samples for Accelerated and Controlled Room Temperature studies.

• Generating stability data for the ANDA applications by following Stability protocol, Stability reports as current

USFDA requirements and by using analytical equipments such as HPLC, UV Vis Spectrophotometer,

Photofluorimeter, Gas Liquid Chromatography and conducting tests such as Assay, Related Substances (Impurity

profile), Dissolution, water content determination by using Karl Fisher Titration, Loss on Drying, Thin layer

chromatography, physical testing(bulk density, tapped density and particle size determination) etc.

• Conducting calibration and preventive maintenance of all laboratory instruments.

• Performing all the tests in a cGMP regulated environment using VELQUEST electronic documentation system.

• Analyzing and troubleshooting chemical process techniques and methods for solution to technical problems.

• Analyzing of raw materials, packaging materials, semi finished and finished drug products.

• Preparation of Standard Test Procedures, Standard Operating Procedures, specifications and stability protocols.

Ranbaxy Laboratories Limited, Mohali, India (Dec 2009 Jan 2010)

Helped in the filing of ANDAs, post approval amendments CBE 0, CBE 30, Prior Approval Supplement (PAS) and

Annual reports as per the current eCTD format.

Undergraduate Thesis (Oct 2006 –April 2007)

Isolated, biochemically characterized and optimized a microbial strain for the production of Dextran.

Performed fermentation studies, growth kinetics, production kinetics and biochemical identification tests to characterize

our strain.

Ranbaxy Laboratories Limited, Research & Development Centre, Gurgaon. (Summer 2005):

Area: Gene cloning and expression of cloned gene

Worked in the Cell and Molecular Biology lab, and performed the various techniques involved in gene cloning and

expression.

Professional societies: Active member of RAPS (Regulatory Affairs Professional Society), NJ/NY Chapter

LABORATORY SKILLS

Water by KF Dissolution Related Substances

Gas Liquid Chromatography Conductivity Tapped density testing

UV Vis Spectrophotometer pH meter Tablet content

Thin Layer Chromatography Particle size uniformity determination

Content Uniformity determination Ultra High Performance

Assay to determine drug Malvern liquid Chromatography

potency master sizer Blend Uniformity testing

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