Julia Sable Email and Phone Number
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Experienced Leader in Cell and Gene Therapy, Vaccines and Oncolytic Virus Manufacturing. Focus on continuous vector manufacturing scale out, analytical assay development and new PATs, tech-transfer, early and late-phase process development studies. Extensive experience in authoring IND, IMPD, GMO and BLA submissions with cross functional quality, reg-CMC and MSAT teams. Prior to industry, she managed the prestigious laboratories of Michael P. Sheetz, Charles Rice and Rafael Yuste where she focused on virus tool and advanced imaging systems for super-resolution and deep-brain imaging. She established her lab as the Director of Virology for the Zuckerman Institute for Mind Brain and Behavior at Columbia University where she specialized in AAV, Lenti, Retro and Rabies platforms for neuroscience research. I am a creative problem solver with a focus on continuous process improvement and performance enhancement. Experience in Aseptic Processing, External Supply Chain and Demand Planning, Regulatory authoring, Quality Auditing, Facility start-ups, change management and CAPAs, and Lean Manufacturing Standards. Strong communicator and talent champion.
Kite Pharma
View- Website:
- kitepharma.com
- Employees:
- 3935
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Director Cmc Project ManagementKite PharmaPhiladelphia, Pa, Us
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Director Viral Vector Process DesignKite Pharma Feb 2023 - PresentSanta Monica, California, Us
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Director Cmc Project ManagementTmunity Therapeutics Incorporated Jan 2022 - Feb 2023Philadelphia, Pa, UsI work with an exceptional team of pioneers in Cell Therapy as a key player to bring leading-edge T cell engineered medicines to patients with solid tumors. Key Responsibilities:Management of integrated project timelines and reporting to cross-functional teams.Pair with CMC regulatory to ensure regulatory deliverables are met.Team communication strategies -
Associate Director, Viral Vector DevelopmentLegend Biotech Sep 2020 - Jan 2022Somerset, New Jersey, UsSME for CDMO/CMO external viral vector manufacturing and LVV DS release in adherent and suspension platforms (the USA, UK, and China) IND and BLA authoring for pipeline LVV DS productsAuthor of SOPs for GxP viral vector manufacturingCMC Lead for internal viral vector platform development for upstream and downstream LVV manufacturing. - Design and implementation for upstream LVV in scalable STR systems - Design and implementation for downstream extensive molecule purification. - Design for HTP analytical assays for LVV potency, particles, residuals, and viral characterization -
Director, Pre-Clinical Vector CoreGene Therapy Program | University Of Pennsylvania May 2020 - Sep 2020Philadelphia, Pennsylvania, Us -
Senior ScientistMerck Sep 2018 - Jun 2020Rahway, New Jersey, UsMRL, VPD, BioProcessUpstream Lead for cross-functional development teams for an oncolytic virus therapy with iCellis Nano and Univercells fixed-bed reactors. Interface with partner groups in analytics, downstream processing, formulation and manufacturing to ensure robust potency assays and a pathway to potential commercialization for fixed-bed reactor platforms. Lead for externalization GMP campaign for master and working cell banks and virus seeds. Lead for cell train Process Development with responsibilities for a team of 6 and direct liaisons with manufacturing teams to design POC experiments, management of project timelines and head of procurement of supply chain for all aspects of project consumables.Lead for iCellis fixed bed reactor systems for POC. Established baseline MRC-5 OV production protocols for both Applikon and mPath controller systems. Established a high throughput imaging platform for identification of early viral infections via live cell dyes as proxies with both fixed and live cells in PET strips. -
Director Of VirologyColumbia University In The City Of New York May 2016 - Sep 2018New York, Ny, Us• Implemented a complete build out of laboratory for production for AAV, vaccine strain N2C rabies, lenti- and retroviral vector systems• Developed a 10-year business plan including labor, product line growth, scalable consumable costs and capital equipment needs• Lead ZMBBI executive faculty committee to determine future targets and novel molecular tool adoption • Accelerated R&D projects include: Novel fish rabies (SHRV) viral vectors system and self-inactivating vaccine strain N2C rabies for chronic mouse imaging • Produce novel client based plasmids for AAV and lentiviral systems using extensive research knowledge and scientific connections• Train and lead technical staff of 3 for daily production of AAV, rabies and lenti viruses -
Associate Research Scientist (Dr. Rafael Yuste); Coordinator Neurotechnology Center (Ntc)Columbia University In The City Of New York Jan 2014 - May 2016New York, Ny, Us• Developed SOPs for primary tissue culture and AAV virus production• Implemented IACUC, rDNA and HazMat protocols • Maintained all advanced optical setups including 2-Photon, 1- Photon, spinning disk confocal, and Spatial Light Modulator (SLM) holographic imaging systems• Coordinated the Kavli Futures NeuroTechnology Symposium in NYC with 600+ person attendance for first 2 years• Responsible for fundraising efforts from corporate, foundation and private donors yearly operational budget for NTC• Managed an academic yearly projects budget of $3.8M. Maintained all lab financial reporting using ARC and FDS reporting systems. Negotiated all purchasing for capital equipment, service contracts, and general lab supplies
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Laboratory Manager Laboratory For Infectious Disease (Dr. Charles Rice)Rockefeller University Jul 2010 - Jan 2014New York, Ny, Us• Managed a laboratory infrastructure and day-to-day operations of the 60+ person, 4 PI Laboratory for Virology and Infectious Disease• Manager of Tissue Culture Core: Oversaw production, purchasing, and QC to provide many transformed cell lines, primary hepatocytes and immune (CD34+) stem cells• Manager of Virology Core: Supervised production and QC for lentivirus, adenovirus, AAV and BSL2 viruses such as HCV, DENV, CMV• Developed modified serum free production with large volume concentration via TFF systems for HCV and DENV production• Manager of BSL3 Viral Facility: Maintained facilities and developed SOPs for production of YF, WNV, CKGN, non-human HCV and chimeric HCV• Developed a new large blood draw multi-serotype DENV protocol and maintained 6 existing IRBprotocols for lab MDs• Developed and maintained IBC (rDNA) and NYS Tissue Bank protocols -
Senior Research Associate (Dr. Michael P. Sheetz)Columbia University In The City Of New York Jan 2000 - Jul 2010New York, Ny, Us• Lead 2 major research projects on in vivo dynamics and of PIP2 and Mechano-differentiation of human iPSC lines. Oversaw grant writing and quarterly meetings the PN2 Nanomedicine Center for Mechanical Biology from the NIH with 13 academic and clinical PIs• Managed the laboratory infrastructure and day-to-day operations of a 30+ person research laboratory • Manager of tissue culture facility that provided transformed and primary fibroblasts for multiple labs• Design of advanced microscopy systems, including Laser Tweezers, TIRF (with FRAP and TRAP), and Confocal• Developed and standardized equipment maintenance, managed repairs and developed safety SOPs for optical and lithography projects• Managed an academic yearly projects budget of $1.7M. Negotiated purchasing for capital equipment, optical systems service contracts, and general lab supplies.
Julia Sable Skills
Julia Sable Education Details
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Columbia UniversityDoctor Of Philosophy - Phd -
Teachers College, Columbia UniversityScience Education
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Youngstown State UniversityBiology- Genetics
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Youngstown State UniversityGeneral
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Columbia UniversityMaster Of Philosophy - Mphil
Frequently Asked Questions about Julia Sable
What company does Julia Sable work for?
Julia Sable works for Kite Pharma
What is Julia Sable's role at the current company?
Julia Sable's current role is Director CMC Project Management.
What is Julia Sable's email address?
Julia Sable's email address is ju****@****ech.com
What is Julia Sable's direct phone number?
Julia Sable's direct phone number is +164628*****
What schools did Julia Sable attend?
Julia Sable attended Columbia University, Teachers College, Columbia University, Youngstown State University, Youngstown State University, Columbia University.
What skills is Julia Sable known for?
Julia Sable has skills like Cell Biology, Fluorescence Microscopy, Confocal Microscopy, Elisa, Life Sciences, Immunology, Flow Cytometry, Assay Development, Virology, Laboratory Safety, Human Subjects Research, Protocol Design.
Who are Julia Sable's colleagues?
Julia Sable's colleagues are Gabriela Kristapaviciute, Mehtap Ayna, Jennifer L. Anderson, Sergio Alvarez, Chaitu Vedam, Michael Kamps, Bianca Bobo.
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