Joseph Vitale Email and Phone Number
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*ACCELERATING PRODUCT ADVANCEMENT THROUGH CLINCAL TRIALS AND COMMERCIALIZATION*As a versatile Cell and Gene Therapy (CGT) leader, business leader and patient-centered CGT innovator, I am at my best when I am developing and delivering therapies at the sponsor and CDMO level. Leveraging a deep understanding of people and process engagement, I focus on getting the best out of peers, reports, customers, and stakeholders to drive advances in CGT Technology.Those I have worked with will tell you that I am a collaborative Senior MSAT leader and patient-centered CGT innovator with significant success in all stages of the product life cycle including product development, technology transfer, IND submission, routine manufacturing/QC, and process validation. Some notable contributions include:• Shepherding clinical stage CGT companies and CDMOs from early pre-clinical development through preclinical development, technology transfer, IND submission/approval and clinical trial.• Launching drug product pre-clinical development at the lab level and laying the groundwork for future facilities development and manufacturing of clinical trials at Imvax. • Establishing an account management department at Minaris Regenerative Medicine while supporting operational and business development integrations with both European and Japanese facilities. • Fueling development of Imvax’s lead investigational product, focused on delivering personalized, whole tumor-derived immunotherapies. • Leading process optimization and technology transfer activities at Minaris, a respected cell therapy CDMO. • Driving advances in software development at TrakCel Ltd, a startup provider of integrated CGT software solutions. • Successfully transferring manufacturing process into external CDMO and internal facility.• Leading the successful technology transfer of various CGT products as an MSAT Product Steward.Skills: Cell and Gene Therapy Technology | Biotech | GMP Documentation | Technology Transfer | Business Development & Management | CMO Relations and Management | Business Partnering & Collaboration | CMC and IND Preparation | Project Management | CAR-T, TCR, CD34+ and other cell therapy modalities | Product Stewardship for Investigations |Manufacturing Science & Technology (MSAT) | Training, Coaching & Mentoring | Process Development & Bioprocessing | Business Startup and Growth |Analytical Development and Qualification | Business Partnering & Collaboration| High Performance Team Building
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Johnson & Johnson Innovative MedicineNew York, Ny, Us -
Principal, Global Msat, Car-TJohnson & Johnson Innovative Medicine Oct 2023 - Present -
Head Of Manufacturing Science And Technology (Msat) And Process Development (Pd)Imvax, Inc. 2020 - 2023Philadelphia, Pennsylvania, UsHired as Imvax’s first Technical Operations leader. Built the foundation for a technical operations organization supporting drug product pre-clinical development at the lab level. Initiated a Phase 2 study for this clinical-stage biotechnology company developing personalized, whole tumor-derived combination immunotherapy product. Drove development of GMP-compliant drug product manufacturing processes. Led the transfer of manufacturing processes into the company’s Manufacturing and Quality Control departments. Facilitated preparation and submission of IND. Collaborated with IP lawyers to establish patents and protect trade secrets. • Laid the groundwork for future facilities development and manufacturing in clinical trials. Functioned as key point of contact for two external CDMOs throughout entire tenure. • Helped develop the technical operations team and established the PD department conducting key IND-enabling studies. Built the MSAT department and PD lab. Facilitated hiring of key personnel in company’s manufacturing, supply chain and logistics departments. • Transformed a paper-process into a tangible GMP manufacturing process that was successfully transferred into operations at Imvax and external CMO; submitted IND and received rapid approval to initiate phase 2 study for Glioblastoma.• Partnered with functional heads of Technical Operations, Quality, Clinical, Medical and Regulatory functions to drive development of Imvax’s lead investigational product. Shepherded a 2nd product from pipeline screening to IND completion for Phase 1. • Leveraged a deep understanding of contract manufacturing and development costs to enhance CDMO performance and achieve a successful technology transfer of products into an external CDMO. -
Director, Account Management, Business DevelopmentMinaris Regenerative Medicine 2018 - 2020Tokyo , Japan , JpBrought back to establish account management department and add value to the customer experience for CGT clients of this leading global CDMO. Positioned Minaris to remain competitive in its market, expand its customer base and grow revenue. Took the lead in vetting alignment, preparation and delivery of Agreements and SOWs critical to new business development.• Helped the organization meet revenue targets for first time in company’s existence. • Established the account management department across three facilities in New Jersey and California. • Supported operational and business development integrations with both European and Japanese facilities. -
Director Of Process EngineeringTrakcel 2017 - 2018Waterfront 2000, Cardiff, GbServed as a cell therapy SME for this startup provider of integrated cell and gene therapy software solutions. Enabled clients to accurately scope projects and precisely manage, control and track cell and gene therapy product development.• Supported design and implementation of autologous chain of identity/custody software platforms designed uniquely for each cell therapy clinical and manufacturing supply chain. • Ensured proper configuration and alignment of bespoke platforms with clients’ cell therapy supply chain and manufacturing processes.• Accelerated delivery times by collaborating with the project team to ensure a full understanding of client requirements related to software development. -
Senior Biomedical Engineer, MsatMinaris Regenerative Medicine 2015 - 2017Tokyo , Japan , JpFormerly PCT and HCATS (Cell and Gene Therapy CDMO) Led process development/optimization and technology transfer activities at this cell therapy CDMO as the industry experienced rapid growth. Directed client projects while successfully managing several key accounts. Filled a resource gap at the project and lab level while moving them closer to product commercialization. Authored strategic manufacturing assessment reports for both early stage and late-stage clinical phase companies.• Served as a subject matter expert for multiple cell therapy product types, leveraging a deep knowledge of manufacturing for T-cell oncology (CAR-T, TCR, etc), CD34+ cells, NK cells and other cell therapy product types. • Drove development of an end-to-end closed clinical manufacturing process as well as development and technology transfer of three T-cell manufacturing processes.• Developed and transferred several CAR-T processes into manufacturing and quality control.
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Scientist, PdMinaris Regenerative Medicine 2013 - 2015Tokyo , Japan , JpSame as above
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Postdoctoral Research FellowMount Sinai Medical Center Jan 2012 - Dec 2013New York, Ny, UsDepartment of Hematology and Medical Oncology.
Joseph Vitale Skills
Joseph Vitale Education Details
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Rutgers UniversityCell/Cellular And Molecular Biology -
Montclair State UniversityBiochemistry
Frequently Asked Questions about Joseph Vitale
What company does Joseph Vitale work for?
Joseph Vitale works for Johnson & Johnson Innovative Medicine
What is Joseph Vitale's role at the current company?
Joseph Vitale's current role is Senior Cell & Gene Therapy Leader.
What is Joseph Vitale's email address?
Joseph Vitale's email address is j.****@****vax.com
What is Joseph Vitale's direct phone number?
Joseph Vitale's direct phone number is +4429204*****
What schools did Joseph Vitale attend?
Joseph Vitale attended Rutgers University, Montclair State University.
What are some of Joseph Vitale's interests?
Joseph Vitale has interest in Science And Technology.
What skills is Joseph Vitale known for?
Joseph Vitale has skills like Cell Culture, Cell Biology, Molecular Biology, Transfection, Flow Cytometry, Immunofluorescence, Cell Therapy, Qpcr, Cancer Immunotherapy, Gmp, Molecular Cloning, Process Optimization.
Who are Joseph Vitale's colleagues?
Joseph Vitale's colleagues are Katja Tendell, Acma, Cgma, Ifeanyi G., Nicholas Lecroy, María José Bracho Gómez, Lialia Safarova, Praful Dandotiya, Kartheek S.
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