Quality Control Assistant

Mihir Shukla

*** ******* *****, ********, ** -***06 ********@*******.*** 716-***-****

A self motivated biotechnologist working in this industry since the last 3 years, with strong background in Biotechnology, Biomedical Science, Pharmacology and Toxicology, very ambitious, known for my enthusiasm, dedication and a good team player. I specialized in aseptic and cell culture techniques, bioreactor operations and process development. I have supervised other lab technologists with great sincerity & success which showed great management & leadership skills.

EXPERIENCE

Bristol-Myers Squibb Company April 2011 - Present Research Scientist (Upstream Process Sciences)

• Hands on experience with bioreactor operations at different scales (5L, 7L, 10L, 15L, 20L)

• Perform mammalian cell culture experiments in shake flasks, wave bioreactors, and glass and stainless steel bioreactors.

• Design, develop and optimize suitable processes for small and large scale recombinant protein production, including culture media, feed strategies and process conditions.

• Design and execute experiments for trouble-shooting issues that occur at higher scale.

• Use and carry out maintenance of laboratory instruments like Vi-cell, Cedex, and Nova on regular basis.

• Provide technical support for upstream processes in manufacturing.

• Troubleshoot and solve any problems with licensed drugs in GMP environment.

• Manage and maintain project reports and process documents.

• Carry out fed batch studies, harvesting process, pellet preparation for metabolomic study using different cell culture techniques.

• Generate new in house expression technologies and bioreactor processes.

• Prepare different media’s using sterile filtration techniques for small and large scale bioreactors/wave bags.

• Conduct and attend project related group meetings.

Contract Pharmaceuticals Ltd. (former Bristol-Myers Squibb) April 2010–April 2011 Microbiologist (QC)

• Manage the microbiological testing of products for sterility, bioburden, endotoxins, and environmental monitoring of production facilities.

• Conduct and examine the microbiological testing of water and air systems.

• Ensures quality system and Good Laboratories Practices (GLP) compliance and approves new and revised SOPs related to Microbiology, Environmental Control and Sterilization.

• Initiate, document, and perform Microbiological analysis on received test samples (including raw materials, bulk, final product, stability, water) as per USP, in-house, or customer methods. Evaluates and records data.

• Analyzes and interpret microbiological testing data. Establish alert and action limits and prepares professional trend reports for management review. Recommend preventive and corrective actions regarding microbiological issues. Provides input for regulatory submissions pertaining to aseptic processing, sterilization validation, environmental monitoring, etc.

• Perform development, maintenance, review, reporting and verification of documents.

• Perform Environmental sampling, monitoring and identification of recovered microorganisms.

• Perform Microbial identifications of microscopic, immunologic, biologic, bacteriological organisms using manual testing and automated systems like Gram Stain, Coagulase test, VITEX, Yeast ID, API strip test according to customers requirement.

• Maintain lab stock cultures for evaluative testing and making dilutions of stock cultures as required by procedure, protocol, or USP requirements.

• Performs Quality Control testing of media, reagents, and identification materials.

• Maintains adequate inventory of media and materials required for testing, conduct calibration of instruments, participate in repair and maintenance of lab equipment and laboratory housekeeping.

• Record and compile data and results into LIMS system, trending of reports accurately, in compliance with applicable cGMP, SOPs and compendia and regulatory requirements.

• Ensure compliance to cGMP in the Quality Control laboratory.

• Participate in all in-house training, education, and Health and Safety programs as required by company/departmental policies.

• Perform quality work within deadlines with or without direct supervision

Department of Restorative Dentistry, SUNY Buffalo Aug 2009 – March 2010 Research Technician I: Dr.Violet Haraszthy

• Media preparation, bacterial counting, spiral platting, staining, antiseptic techniques, inoculation.

• Preparing cultures of tissue samples

• Establishing and monitoring programs that ensure data accuracy

• Microscopically examining slides of bodily fluids

• Analyzing lab reports for accuracy. Operating and calibrating equipments

• Delivering test results to researchers and patients

• Analysis of microscopic, immunologic, biologic, bacteriological test results

Research Experience:

Dr. Shuying Yang’s Laboratory, SUNY Buffalo Aug 2009 – March 2010

• Research support for identifying the role and molecular mechanism of novel or known genes in bone formation and resorption using gene knock out theory.

• Performed microbiological assays like gel electrophoresis, PCR, Western blot, ELISA, extraction and isolation of genomic and plasmid DNA.

EDUCATION

University at Buffalo, the State University of New York

Major: Bachelor of Science in Biomedical Sciences, Biotechnology, Pharmacology and Toxicology May, 2009

Relevant Coursework: Biochemistry; Chemistry of Drug Action; Organic Chemistry I and II; Biochemical Pharmacology; Computer Science; Human Physiology; Immunology; Instrumental Analysis; Microbiology and Anatomy. Courses related to Masters Program

Laboratory Techniques: Enzyme immunoassays; Gel electrophoresis; Polymerase chain reaction (PCR); Use of fluorescent antibodies; Western blot analysis; Southern blotting; microbiology techniques; Thin layer chromatography (TLC); Gas chromatography (GC); High performance liquid chromatography (HPLC)

OTHER EXPERIENCE

Consultant, Computing Information Technology, SUNY Buffalo, 08/05- Present

• Assist customers with any of the software problems in computer lab

• Perform general office duties including typing, filing and answering phones

Chemistry/ Biology Lab Assistant and Stockroom Assistant, SUNY Buffalo, Year 2008

Make chemicals, demonstrate experiments, and take care of stockroom inventory

Computer Skills: Windows Vista; Mac OS X; Microsoft Office, PowerPoint, and Excel; Adobe Photoshop

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