Sridhar Arumugam
Senior Quality Assurance @Cepheid
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WORK HISTORY
Senior Quality Assurance @Cepheid
Sunnyvale, CA, US
EDUCATION
Product School
Product Manager, Product Management
University of Madras
Bachelor of Science (B.Sc.), Microbiology
Loyola College
Master of Science (M.Sc.), Biotechology
The University of Bonn
Doctor of Philosophy (Ph.D.), Microbiology
ABOUT SRIDHAR ARUMUGAM
Experienced Product Development Scientist with key contributions in Assay Development, New Product Introduction, Product Transfer, Technical Project Management, Verification & Validation, Quality Control (QC), Microbiology Product Development & Testing (Antimicrobial Susceptibility Testing - AST, BSL2 pathogens), PPI (Kaizen), CAPAs, Preclinical & Clinical Research, Genomics & Molecular Diagnostics (IVD) & Vaccine Development along with proven experience in IND, FDA 510(K) fillings, Product Development & Commercialization. A detail & result oriented Biopharma Scientist with critical scientific reasoning and hands-on wet laboratory experience and excellent track record in product development.CORE EXPERTISE: Medical Device and Assay Development QA Multiplex assay development and formulation for IVD products Leading product tech transfer from R&D into Manufacturing for IVD products Manufacturing Tech Transfer planning QC method development and release Process capability analysis Guard banding studies QC Specification setting Real time and accelerated stability studies design and execution Sample Preparation (sample matrices including whole blood, plasma, serum, stool, urine, swab) PCR (qPCR, digital PCR, multiplex PCR) Antimicrobial Susceptibility Testing (AST)- CLSI guidelines and Breakpoints | MIC, MBC, Time Kill, Synergy testing, Biofilm testing (MBEC), Post-Antibiotic Effect, Resistance Profiling, Sterility testing, Bioburden, LAL Endotoxin, TOC, Mycoplasma testing Assay development Product development (IVD), Design FMEA Process development, Monitoring & Control, Process FMEA, PPI/Kaizen Microfluidics Liquid Handlers Experimental Design (DOE)| JMP Verification & Validation Contributions to Regulatory Submissions – IND, CMC, 510(K) Design Control, Quality Control & Quality Assurance (QC/QA), OOS, NCMR, CAPAs, SCAR, Ishikawa Diagram - Fish bone (6Ms) Root Cause Analysis, 5s, Internal and External Audits Vaccine Development, ELISA/Immunoassays and in vitro cell based assays Preclinical Research - Lead Optimization | In vivo Studies | IACUC compliance Design Control | GLP I cGMP | BSL-2 lab compliance VoC, CRs, PRs, PS, Competitive Landscape/Competitor analysis, Personas, Value Proposition, Customer & Product requirement synthesis, PRD Efficient Communication Ability to Prioritize Ability to Work in a Matrix Analytical Ability Technical & Cross Functional Knowledge Ability to Work Independently and Collaboratively in a Team
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