Pramod Naranatt Phd Pmp Email and Phone Number
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*Experienced IVD R&D Director, actively seeking new opportunities (Director/ Manager Research, Technical Operations, Project Management, Principal Scientist in Assay Development, Invitro Diagnostics). Open to relocation and Remote positions. *| Director/ Manager Research | Technical Operations | Project Management | Principal Scientist in Assay Development | Invitro Diagnostics |Contact: ppnaranatt@yahoo.com or (626) 840-3820CORE COMPETENCIES:• Broad expertise leading diagnostics development across multiple technologies and platforms • Established track record in leading new product development under design control launching multiple IVD, ASR, GPR products.• Excellent team player, with a proactive attitude to work. • Strong mentoring and management skills. • Proven strategic agility and accomplished at strategic and tactical resource utilization.• Prepared and submitted pre-submission packages to FDA• Lead internal performance studies supporting regulatory submissions.ACCOMPLISHMENTS: • 510(k) clearance of Cystic fibrosis carrier, Warfarin assay and 5 infectious disease assays- Influenza test, HSV, C difficile, Group A Strep Assay.• Coordinated between quality, regulatory, production and QC teams. Collaborated with KOLs to define product requirements for pharmacogenomics assay (Warfarin Test).• Lead high value strategic projects saving money for the organization such as revamping the QC methodology• Lead the redesign, revalidation and relaunch of recalled FDA cleared Simplexa Influenza A/B/RSV Assay.• Multiple platform technologies-eSensor and Integrated Cycler. Please contact me with any potential R&D, QC or project management opportunities.
Fluxergy
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Associate Director, MolecularFluxergy Apr 2019 - PresentIrvine, California, Us
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Sr Director, Product DevelopmentDxterity Nov 2017 - Oct 2018Rancho Dominguez, California, Uso 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. -
Director, Molecular R&D (Us)Diasorin Molecular Llc Apr 2013 - Oct 2017o 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.
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Molecular Diagnostics LeadAntech Diagnostics Dec 2010 - Apr 2013Fountain Valley, Ca, Uso 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 -
Molecular Dx -Group LeadProteogenix Inc Mar 2008 - Dec 2010o 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
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Senior Staff ScientistGenmark Diagnostics Mar 2004 - Mar 2008Carlsbad, Ca, Uso 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 -
Research Asst ProfessorUniversity Of Kansas Medical Center Mar 2003 - Mar 2004Kansas 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
Pramod Naranatt Phd Pmp Skills
Pramod Naranatt Phd Pmp Education Details
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University Of Kansas Medical CenterMolecular Virology -
University Of MadrasMolecular Biology
Frequently Asked Questions about Pramod Naranatt Phd Pmp
What company does Pramod Naranatt Phd Pmp work for?
Pramod Naranatt Phd Pmp works for Fluxergy
What is Pramod Naranatt Phd Pmp's role at the current company?
Pramod Naranatt Phd Pmp's current role is R&D Director | Manager | Program Leader | Assay Development | Technology Transfer | QC | FDA | Diagnostics | IVD |.
What is Pramod Naranatt Phd Pmp's email address?
Pramod Naranatt Phd Pmp's email address is pp****@****hoo.com
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Pramod Naranatt Phd Pmp's direct phone number is +162684*****
What schools did Pramod Naranatt Phd Pmp attend?
Pramod Naranatt Phd Pmp attended University Of Kansas Medical Center, University Of Madras.
What are some of Pramod Naranatt Phd Pmp's interests?
Pramod Naranatt Phd Pmp has interest in Human Rights, Children, Environment, Health.
What skills is Pramod Naranatt Phd Pmp known for?
Pramod Naranatt Phd Pmp has skills like Molecular Biology, Lifesciences, Cell Culture, Assay Development, Biotechnology, Rt Pcr, Pcr, Elisa, Fda, Flow Cytometry, Qpcr, Immunology.
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