Thillai Sathi Sathiyaseelan
About
Thillai Sathi Sathiyaseelan is from Lexington, Massachusetts, United States. Thillai works in the following industries: "Pharmaceutical Manufacturing". Thillai is currently Research Manager (Part-time), Vaccine Development Projects at Vaxine Pty Ltd. Thillai also works as Consultant (Part-time) at Avaxia Biologicals, a job Thillai has held since Apr 2012. In Thillai's previous role as a Consultant (Part-time) at SmartCells Inc, Thillai worked in Beverly, MA until Mar 2012. Prior to joining SmartCells Inc, Thillai was a Director, Bioanalytical Development at SmartCells, Inc and held the position of Director, Bioanalytical Development at Beverly, MA. Prior to that, Thillai was a Consultant/Contractor, Bioanalytical Development at SmartCells Inc, based in Beverly, MA from Jun 2010 to Jul 2010. Thillai started working as Sr. Manager (Vaccine Preclinical Development Projects) at Vaccine Research & Development in South Australia in Nov 2007. From Dec 2002 to Nov 2007, Thillai was Director (Immunology R&D; Therapeutic Antibody Development) at Hematech Inc, based in Sioux Falls, SD. Prior to that, Thillai was a Scientist (Diagnostic Assay Development) at Repromedix Corp from Jan 2000 to Dec 2002.
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Thillai Sathi Sathiyaseelan's current jobs
• Guiding scientist teams in South Australia on their vaccine research projects (via skype, teleconference and emails) including reviewing/streamlining their experimental designs, in-vivo study protocols and data analysis • Writing research grants for new vaccine development projects • Managing United State based collaborative vaccine/adjuvant development projects
• Designing vaccine formulations and optimizing immunization strategy for developing anti-TNF antibody therapeutic
Thillai Sathi Sathiyaseelan's past jobs
• Working as a member of the consulting team that evaluates scientific merits and competency of new life science technology opportunities for acquisition or licensing for a new start-up
• Established GxP laboratory and compliance including SOPs and documentation system; completed pre-validation of PK assays; transferred and managed PK assay validation project at CROs • Liaised with and managed potency testing and data analysis of clinical trial lots at CRO (ZenBio) • Developed and validated GxP bioanalytical assays in-house for nonclinical and clinical PK study sample analysis; completed study sample testing, data analysis and preparation of bioanalytical study reports for regulatory submission • Established and optimized cell based assays for receptor binding studies (insulin receptor, IGF1 receptor, EGF receptor) for lead candidate analysis/selection, cell based bioassay (lipolysis inhibition assay) for potency assessment and anti-drug antibody assays for immunogenicity assessment of therapeutics
• Completed optimization and pre-validation of bioanalytical assays, SOP development, validation of assay controls and assay transfer documentation, and managed transfer of bioanalytical methods to CRO for GxP validation and GLP-study sample analysis
• Directed scientist teams that performed bioanalytical development & preclinical testing of vaccine and adjuvant products; streamlined laboratory set-up and SOPs, and strengthen the bioanalytical system to GxP-standards; established quality compliance and documentation system • Supervised/managed scientist group that carried out R&D testing for new vaccine products, including reviewing/approving in-vitro and in-vivo study designs/protocols and data analysis, troubleshooting and optimizing testing methods/assays (product specific antibody assays, cell based neutralizing antibody assays, cell-based in-vitro bioassays, T cell response assays (proliferation and cytolytic killing assays), ELISAs, ELISOPTs, and multiplex flow cytometry cytokine/chemokine biomarker assays) • Coordinated sample collection and testing procedures with clinical trial groups, and supervised study sample testing, data analysis and report submission for clinical studies • Coordinated and managed preclinical toxicity study at CRO; prepared bioanalytical portion of technology transfer documentation and transferred bioanalytical test methods to CMO for stage 2 manufacturing, sterile filling and release of clinical trial adjuvant lots
• Led Immunology R&D group and directed bioanalytical assay development and testing of transgenic animal tissue/cell samples, transgenic cattle derived therapeutic antibody product samples to support discovery and R&D • Developed and optimized assays for evaluating immune system and immune responses of knockout/transgenic cattle (immunoassays, flow cytometry assays, protein assays, immunohistochemistry, PCR/molecular assays, FISH analysis) and for testing therapeutic antibody products (ELISAs, neutralizing assays, cell based potency assays, and protein assays). • Qualified/validated and transferred ~30 GxP assays for in-process testing and product QC testing • Successfully completed early development of multiple therapeutic antibody development products derived from transgenic cattle (anthrax antibody therapeutic, anti-botulinum toxin therapeutics, anti-T cell immunotherapeutic and MRSA antibody therapeutic) • Established GLP-laboratory and regulatory compliance documents (SOPs, assay validation & assay transfer procedures, deviation reporting)
• Developed and validated diagnostic assays for testing of clinical samples from infertility/reproductive disorder patients • Coordinated two clinical studies in collaboration with outside research institutions for clinical validation of disease diagnostic biomarkers