Pramod Naranatt Phd Pmp Email & Phone Number

Irvine, California, Us

Rancho Dominguez, California, Us

o Led cross functional teams to develop and transfer biomarker based LDTs to CLIA lab.o Collaborated with business development, and finance to support externally funded pharma projectso Led design control documentation, technical reviews and phase reviews.o Prepared and submitted two FDA pre-submission applications.

o Led teams that developed and commercialized reagent and consumables kits for Diasorin’s Integrated Cycler platform. My teams developed 4 product launches.o Led the redesign and relaunch of the recalled flagship product, Influenza A/B RSV Assay.o Revamped the QC testing resulting in $80K saving to the organization.o Led technology improvement efforts to reduce Assay time. o Led development of FII, FV genotyping assays and companion Dx assay for Copaxone efficacy.o Led efforts to close CAPA, represented R&D in product change process, MRB, Senior Management and R&D reviews. o Developed multiple ASR assays including MERS-CoV and Zika virus.o Significantly improved quality and reliability of product development timelines and budget through PM best practices. o Improved the design control procedures leading to greater customer satisfaction and company performance and confidence.

Fountain Valley, Ca, Us

o Led technology and development of Molecular Dx assays. o Designed and developed multiplex molecular diagnostic assays to detect bacteriae, virus, and parasites (Respiratory, GI, Tick-borne infection panels).o Managed all aspects of product development.o Developed a variety of next-generation assays like SNP detection, bioinformatics-based viral differentiation, and viral virulence testso Developed QC testing ranges for existing assays and developed script driven algorithms for QC testing and sample calling.o Real-Time PCR test for Pathogenic Leptospira detectiono Viral Differentiation Assays: genomic motif for wild-type vs vaccine strainso Viral Virulence Test: Feline Infectious peritonitis virus detection

o Established a Molecular Diagnostics group and launched 4 assays in CLIA lab. o Developed ELISA for two biomarkers as part of pre-term birth risk panel.o Developed verification and validation protocols, managed product performance claim studieso Improved Assay robustness through DOE and Statistical variance studieso A significant contribution to process development / technical transfer to the Operations groupo Introduced JMP scripts to automate data analysis for clinical sample calling.o Real Time PCR: Bacterial detection in human amniotic fluid o Pyrosequencing: Bacterial identification in Sepsis

Carlsbad, Ca, Us

o Developed products in IVD (in vitro diagnostic) environmento Multiplex PCR (16plx, 8plx) design, DOE optimization for uniform representation of all locio High Selectivity and High-Efficiency Probe and Primer Designo Supervising: Supervised Scientists and Research Associateso Developed and validated customer-friendly run control alerts o OSMETECH Monumental Award for outstanding contributions 2007o Developed Cystic Fibrosis carrier detection and Warfarin assays (FDA 510(k)o Coordinated requirements management through KOLs (Pharmacogenomics assay)o Developed and validated customer-friendly run control alert algorithm o Supported Client Service by acting as the technical and scientific resourceo Assisted Sales and Marketing departments by providing technical literature, training for clientso Validated processes and developed product specificationso Reduced development cost by price negotiation with OEM vendors.o Human SNP Genotyping: Cystic Fibrosis screening Assay: (510(k) cleared o Pharmacogenomics Assay: Warfarin Sensitivity Test : (510(k) cleared o Phase 0 feasibility: Cytochrome 2D6 polymorphism, Respiratory panel

Kansas City, Ks, Us

• Identified several viral entry and infection mechanisms• Co-invented integrin alpha3 beta1 as HHV-8 receptor• Wrote 2 grant proposals and 10 research publications• Cell Signaling: Identified Signal cascade that aid virus entry• Microarray: gene expression in target cells utilized by virus• Monoclonal and polyclonal antibody development• Mastered most molecular biology techniques• Participated in many conferences and seminars

Postdoctoral Fellow, Molecular Virology

Phd, Virology, Molecular Biology