Shreya Datta, Phd Email & Phone Number

Portland, OR, US

Portland, Oregon, United States

Portland, OR, United States

• Biocompatibility program management: Establish and manage a robust biocompatibility program for NuVasive devices to maintain compliance with the current regulatory standards.
• Support coordinating biocompatibility testing at CROs, author and/or approve Biological Evaluation Plans and Reports (BEP and BER), collaborate with SMEs on toxicological risk assessment reports.
• Author/review reports to support FDA, EU MDR and other regulatory submissions of new and legacy devices with a coordinated effort within cross-functional teams.
• Actively participate in CAPA, HHE and RCA activities.

Hillsboro, Oregon

• Biocompatibility program management: Lead a cross-functional team to drive biocompatibility efforts to maintain compliance with the current regulatory standards, create AFEs, oversee budget and expenditure
• Conduct and/or manage outsourced preclinical (GLP), analytical chemistry studies with CROs
• Technical lead, author and/or approve Biological Evaluation Plans and Reports (BEP and BER), collaborate with SMEs on toxicological risk assessment reports
• Author/review reports to support validation activities, EU MDR and other regulatory efforts
• Actively participate in CAPA, HHE and RCA activities
• Support manufacturing cleaning validation activities and defining product specifications

Hillsboro, Oregon

• Actively involved in regulatory submission of new products including combination products as a part of a cross-functional team that includes product managers, product engineers, process engineers, quality engineers.
• Provide microbiology technical expertise
• Provide validation support by interfacing with external test laboratories
• Draft test protocols, reports and technical reports
• Author and review internal SOPs, Work Instructions
• Participate in risk management activities following ISO 14971

Portland, Oregon Area

• Study retinal degeneration in mammalian retina:
• Map the serotonin receptors in mammalian retina in transcriptional and translational level.
• Investigate the cell signaling pathways involved in retinal neuro-protection to aid drug development for Retinitis Pigmentosa in eyes.

Portland, Oregon Area

• Study bacterial pathogenesis:
• Study the role of iron transport system in human pathogenic bacterium V. vulnificus infections: Characterization of the heme transport system; Determination of virulent factors in the microorganism.
• Investigate the mechanism of siderophore assembly in fish pathogenic bacterium V. anguillarum: Characterization of the biosynthetic genes involved in the assembly of siderophores, anguibactin and vanchrobactin.

• Drug Discovery and Development:
• Protein-Protein Interaction Study: Construction and characterization of two-hybrid genetic selection systems to study protein-protein interactions.
• High Throughput Assays: Selection and characterization of inhibitors of protein-protein interactions in various diseases.
• Peptidomimetics: Solid Phase Peptide Synthesis (SPPS) of combinatorial libraries,column chromatography and HPLC purification of small molecules.

Ph.D., Chemistry

Activities and Societies: American Chemical Society (ACS)

Int. Ms, Industrial Chemistry