Jaison Paliakkara Ph D RAC
About
Jaison Paliakkara Ph D RAC is from Malden, Massachusetts, United States. Jaison is currently Biotechnology and Biopharmaceutical Professional at Independent Consultant, located in Greater Boston Area, MA, USA. In Jaison's previous role as a Director of CMC and Regulatory Affairs/Global Process Development Steering Committee at Batavia Biosciences, Jaison worked in Woburn, Massachusetts, United States until Feb 2024. Prior to joining Batavia Biosciences, Jaison was a Director of Process Development/CMC/RA/Global PD Steering Committee at Batavia Biosciences and held the position of Director of Process Development/CMC/RA/Global PD Steering Committee at Woburn, Massachusetts, United States. Prior to that, Jaison was a Principal Scientist - Cell & Gene Therapies - Process Development/Stability/CMC/Regulatory Affairs at Sigilon Therapeutics, Inc., based in Cambridge, Massachusetts, United States from Jan 2021 to Dec 2021. Jaison started working as Principal Scientist/Manager - Cell & Gene Therapies/Viral Vectors/Data Analytics/Project Management at Thermo Fisher Scientific in Cambridge, MA, USA in Jan 2019. From Jan 2018 to Jan 2019, Jaison was Principal Scientist - Process Sciences/C>/Viral Vectors/Data Analytics/Project Management at Brammer Bio, based in Cambridge, MA, USA. Prior to that, Jaison was a Principal Scientist - Protein Sciences/Data Analytics/Regulatory Affairs/Project Management at Paliakkara Corporation, based in Greater Boston Area from Jan 2016 to Jan 2018. Jaison started working as Principal Scientist - Enz. Replac. Therapies/QC/Data Analytics/Regulatory Affairs/Project Management at Takeda in Lexington, MA, USA in Jan 2015.
Jaison Paliakkara Ph D RAC's contact information is available for free on finalscout.com, a web-based professional networking database with more than 500 million business contacts and 200 million company profiles.
Jaison Paliakkara Ph D RAC's current jobs
Jaison Paliakkara Ph D RAC's past jobs
Viral Vectors/Vaccines/Cell and Gene Therapies/Protein Therapeutics/CMC/Regulatory Affairs
Process Characterization - Upstream and Downstream - Pharma Services - Viral Vector Services - Project Management - Data Analytics
Process Characterization - Upstream and Downstream - Project Management - Data Analytics
Protein Sciences/Glycoanalysis/Small Molecules/Formulation Development/Analytical Development QC/Regulatory Affairs/CMC/IND/BLA/NDA/eCTD Therapeutic Fusion Proteins and Monoclonal Antibodies - Purification and Characterization Anti-cancer Therapeutics -Exploratory R&D and Preclinical Development/Management of Clinical Trials Project Management and Statistical Data Analysis
Shire Pharmaceuticals - Pharmaceutical Project Management Predictive and Agile Approaches, Lean Thinking - Team Focused Methods and Scaling Frameworks. Data Analytics and IT - SAS (Clinical Trial Data), SAS-JMP14, JMP Pro, JMP Clinical, JMP Genomics, SAS Visual Analytics, Base SAS, Python and R. PerkinElmer Living Image and TIBCO Spotfire Regulatory Affairs/QA/QC/Documentation EDMS (eCTD, LIMS, TrackWise and MasterControl RAC (US) June 2017-2020 Clinical Research (GCP) data analysis - germline allele variations (clinVar), GWAS and GTEx - Evaluation of patient blood and biopsy tissue samples (Microarray, Histopathology, Immunochemistry, Quantitative Real Time RT-PCR, Immunoglobulin Quantification by Nephelometry, etc.), Statistical Data Analysis and employing Next Generation Sequencing techniques. Development of Protein Therapeutics (cGMP) Protein Sciences and Glycobiology - Protein Purification and Characterization, Lean Six Sigma Foundations, Protein-drug conjugation, Enzyme kinetics, SDS-PAGE, 1D/2D, Western Blot, LC-MS, SEC, IEX, RP-HPLC, Peptide Mapping, Aggregate and High Molecular Weight Analysis, Oligosaccharide Profiling, Charge Variants Determination, ELISA, SPR (BIAcore), Isolation of human primary T Lymphocytes and generation of monolayers, Apoptosis assays, FACS analysis, Detection of caspases, Cell Based Assays, IHC, PCR, Nucleic acid based assays etc. Client: SHIRE PHARMACEUTICALS, Lexington, MA Project Accomplishments: Data Management and Regulatory Filings (QC/ RA/ cGMP) Objectives: To evaluate commercial drug product quality and performance of analytical test methods using quality control release data. Outcome: Created reports were approved by signatories on MasterControl and used for required regulatory submissions. Role: Managed and organized data collection from different cross-functional areas and employed EDMS (LIMS, TrackWise and MasterControl) and statistical data analysis to enable visualizations of descriptive and inferential data.
Olympus Biotech America - Project Accomplishments: Building and Managing an R&D Laboratory for Anticancer Research Objective: To set up a laboratory for identification of protein based cytotoxic or cell proliferative therapeutics. Outcome: Executive report highlighting the conclusions drawn out of the experiments, along with reagents, SOPs, equipments, lessons learned etc. was submitted to senior management sponsors. Presented the data with conclusions drawn. Role: Developed the concept, estimated time, cost and activity to execute the scope, created a procurement plan, Identified and assigned staff, created schedules for shipment, installation, qualification, staff training, chartered, planned and executed the project. Paliakkara Corporation, Malden, MA, USA (July 2014 – September 2015) Principal Scientist – Preclinical Anticancer Therapeutics Project Accomplishments: Management of Assay Development for Anticancer Drug Screening (IVD). Objective: To develop in vitro 3D co-cultured tumor spheroids assay platform using cross-linked Alginate-Chitosan (disease-in-dish) to screen anticancer therapeutics for personalized cancer therapy. Outcome: Created technical report by incorporating details about the reagents, SOPs, equipments, statistical data analysis software tools, conclusions drawn, lessons learned and details about the document creation. Role: Developed the concept, estimated schedule, cost and activity to execute the scope in consultation with SMEs, chartered the project, arranged finance, applied for funding and executed the project as per the plan.
Preclinical Anticancer R&D (GLP) - Immuno-Oncology, Toxicity/Efficacy, In vivo small animal imaging, In vivo corneal wound healing studies, Corneal Cup ELISA, Corneal Keratitis studies, Protein-Drug Conjugation, Drug Delivery to Solid Tumors, 3D Tumor Spheroid Assay etc. Project Accomplishments: Management of Drug Delivery to Mouse Tumor Models (Preclinical - GLP) Objective: To evaluate the efficacy and toxicity of small molecule anti-cancer compounds (substrates and inhibitors of serine proteases) in syngeneic mouse tumor models. Outcome: Created preclinical study reports highlighting therapeutic intervention outcome with detailed procedures used to generate anticancer drugs, animal testing protocols, data analysis software, lessons learned and details about the document creation. Role: Developed the concept, estimated time, cost and activity, chartered the project, obtained study approval from DLAM as per GLP requirements, assigned personnel, procured mice, planned study and arranged to record data, etc.
Glyco-Immunology Biologics Process Development and Manufacturing Broadly Neutralizing Antibodies In Vitro Sialylation of Intravenous Immunoglobulins (IVIG) Removal of galactosyl transferase and sialyl transferase from sialylation reaction mixture by Ion Exchange Chromatography. Xeno-reactive Antibody (anti-alpha-Gal) purification from human plasma, physico-chemical characterization and identification of its endogenous glycoconjugates.