Email: yadav.sapna.r@gmail.comCell Phone: (510) 909-5208

SAPNA R. YADAVCareer Summary

3+ years of experiences in Life Sciences and Biotechnology industries Success in working as an individual contributor and team leader within a cross-functional team to

achieve results Detailed oriented as well as results oriented. Strong verbal and written communication skills.

Education

San Jose State University, San Jose, CABachelor of Arts in Biological Sciences – December 2010

Kriger Research CenterCertification in Clinical Trial Monitoring and Research Site Coordination – June 2012

Professional Experience

ThermoFisher Scientific (Formally Life Technologies) (August 2013 to Present)Quality Control (QC) Lead, Scientist I, Open Array

Gained knowledge in verifying quality of DNA arrays via Genotyping System that provides PCR-based SNP analysis and/or Gene Expression System that provides PCR-based RT analysis.

Operate equipment such as OpenArray Accufill Autoloaders, Applied Biosystems GeneAmp PCR System 9700, Quant Studio 12K Flex Real-Time PCR system, and OpenArray NT imager on daily basis.

Oversee the day to day responsibilities of the manufacturing process and ensuring product quality of the OpenArray instruments and consumables with a focus on TAT.

Implement daily team huddles with involvement from all tier levels from the manufacturing floor to the leadership team to report issues and request proper support.

Responsible for customer order prioritization that come through for QC testing. Gained knowledge in data analysis for all OpenArray product types such as SNP, GEx and miRNA. Revise current Standard Operating Procedures (SOPs) to keep with constant process improvements as well as

create and own new SOPs and /or Work Instruction (WIN) documents. Daily use of systems such as TrackWise and Agile to create PRs, DCO/ECO, ECR, and CAPA. Responsible for making Genotyping DNA plates according to specific guidelines and dilutions by utilizing pipetting

techniques. Responsible for scheduling preventive maintenance (PM) and/or calibrations on all operating equipment and

pipettes. Continue to maintain current Good Documentation Practice (cGDP) and proper 6S activities according to the

proper guidelines within the laboratory. Promoted to QC Lead position in March 2014 Trained and certified in Practical Process Improvement (PPI) 8-step process Participate in a GEMBA walk program to identify process improvements.

Life Technologies through Kelly Services (March 2013 to August 2013)

Associate Manufacturing Technician, Custom Primers Synthesize DNA oligonucleotides/custom primers. Gained knowledge in operating specifically designed semi-automated and automated lab equipment such as

Jurassic and TCAN. Performed laboratory assignments independently as well as in a team. Involved in providing feedback, ideas and suggestions to improve lab techniques and work flow. Maintained current Good Documentation Practice (cGDP) according to the proper guidelines. Performed proper 6S activities within the laboratory.

Clinproxy Research Services (June 2012 to March 2013)Internship

Developing feasible questionnaire, investigator/site contract, practices/SOPs/PDRs/CAPAs, Investigational Brochures, Research Site Evaluation Form, agenda for site initiation, monitoring site visit and close out visit.

Knowledge of standard operating procedures involving basic laboratory techniques, calculations, material measurement, operating of laboratory equipment and record keeping necessary to manufacture products.

Perform designated projects in accordance with applicable SOPs, clinical on-site monitoring activities; drive patient recruitment, source data verification, drug accountability and data collection.

Collecting regulatory documentation, performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines.

Act as an independent CRA on complex or multiple projects, CRA on smaller projects. Understanding of Current Good Manufacturing Practices (cGMP).

Kriger Research Center (March 2012 to June 2012)Student

Thorough knowledge of The International Conference of Harmonization (ICH) and Good Clinical Practice (GCP) Guidelines

Complete understanding with roles of Investigators, Sponsors, CRA’s/CRC’s and IRB/IEC’s

Biology Laboratories (September 2004 to December 2010)

Student Molecular Cell Biology: Practiced techniques such as proper pipetting (manual and electronic), serial dilutions,

vortex, centrifuge, Light and phase contrast microcopy, aseptic/sterilization technique to avoid contamination, liquid and media preparation (maintaining, storage and expansion of E. coli and Mammalian Tissue Culture), DNA manipulation, agarose gel-electrophoresis, genomic DNA purification, density gradient and differential centrifugation.

Biochemistry: Column and thin layer chromatography, fraction collection, spectrophotometry/spectroscopy (UV/Vis), protein and enzyme assays, SDS-PAGE, fermentation

Gained knowledge and experience with the following equipment: Autoclave, PCR, EKG/ECG, EEG and pH meter. Understand laboratory pre-cautions and safety. Collecting and analyzing data.

SKILLS Advanced computer skills in MS Word, Excel, and PowerPoint. Through knowledge of software such as TrackWise and Agile