Product Development Medical Device

SHRUTI NAGRATH

909-***-**** acudr7@r.postjobfree.com

Education

Certificate in Bioscience Management, Keck Graduate Institute (KGI), CA, USA May 2016 Master of Science (Biotechnology), masters, India Aug 2008 Bachelor of Science (Biotechnology), under graduation, India July 2006 Related Coursework

U.S. Regulatory Affairs, Medical Devices and Diagnostics, Pharmaceutical Discovery & Development Relevant Experience and Graduate Projects

Research Lead, KGI Feb - April 2016

Managed a team of 4 and evaluated the regulatory pathway of a Medical Device for FDA approval Product Development Lead – Analytical Verification and Validation, KGI Sep – Dec 2015

Evaluated and validated performance parameters for a robust Point of Care Medical Device to monitor biomarker’s ALT in patients infected with HIV, TB and Hepatitis viruses Technical Analyst – in vitro diagnostics, KGI Sep - Dec 2015

Researched molecular mechanisms, identified diagnostic methods and proposed diagnostic test to clinically validate the biomarkers associated with Multiple Sclerosis Project Lead – Biosimilar Product Development, KGI Oct - Sep 2015

Managed a team of 7, researched therapeutic mechanism, regulatory pathway, strategic process & unit operations to introduce biosimilar of “Remicade” in market Professional Experience

Associate Scientist (Analytical Department), Intas Pharmaceuticals, India 2013 - 2014

Project lead for providing analytical support across 6 departments within the R&D division

Developed risk mitigation strategies throughout the product development cycle

Provided technical expertise for project meetings and prepared timely reports Research Associate (Analytical Department), Intas Pharmaceuticals, India 2010 - 2013

Performed sample analysis for upstream and downstream process development

Analytical method optimisation and qualification as per ICH guidelines

Trained quality control analysts for approval of commercial batch manufacturing process Trainee Research Ass. (Non Infringing Formulation Dept.) Intas Pharmaceuticals, India 2008 – 2010

Designed screening experiments and analyzed stability results for a stable formulation for Gonadotrophins

Responsible for inventory and lab management

Leadership Experience

Lead a team of 25 people to resolve lab issues by conducting weekly departmental meetings

Vice President of Science Club during under graduation Patents

Co-authored “ Thermostable Formulation for Gonadotrophins ” PCT Patent No.: WO2011108010A2 Certifications and Awards

Sidney J Weinberg Jr Foundation Founders Circle Fellowship at Keck Graduate Institute Aug 2015

Post Graduate Certificate in Operations Management, IGNOU University, India Apr 2009 – Mar 2010 Skills

Computer skills: Microsoft project and Microsoft Office Suite

Soft Skills: Work effectively within a team, ability to multi task, strong analytical and problem solving capability, high performance under minimal supervision, written communication skills, quick learner

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