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I am a seasoned life science leader with a passion for developing teams and solutions for life science research, discovery, diagnostics, and therapeutics. I have 30 years of industrial experience in research, protein design, analytical development, validation, cross-functional project/program team management, medical affairs/medical communications, and process development / manufacturing. I have built diverse teams that have successfully developed and launched products in genomics, gene expression, life science instrumentation, IVD diagnostics, and biotherapeutics. I have had the opportunity and fortune to have helped develop and commercialize a wide variety of products from bDNA IVD testing kits or HIV, HBV and HCV viral load (Chiron/Bayer), BigDyeTM Terminator sequencing and other genotyping products (Applied Biosystems), cystic fibrosis and HIV IVD products (Celera Diagnostics), single cell multi-omics reagents (V3 Chemistry), software, and instruments (Mission Bio), to biotherapeutics Kovaltry and Jivi (Bayer). I have served as program lead for early and late-stage biological drug development cross-functional programs including team members from research, process development, toxicology, clinical development, manufacturing, medical affairs, marketing, communications, field training, regulatory affairs, and global quality. I have authored numerous technical documents, including reports, validation packages, vendor qualifications, briefing packages and TRD’s to support regulatory submissions and license applications. I have direct experience with interactions the health authorities including FDA, EMA, PMDA, PEI, MPA, and Health Canada. I have planned and implemented medical studies and communications strategies to prepare for product launch and post launch regional support. I have planned and implemented technical programs to address regulatory issues including MOA studies for liposome formulations, leachable elements in drug delivery systems, protein API and drug product specification setting, extended characterization and comparability studies, unit potency definition and value assignments, and self-life extension plans. I have experience in negotiating and managing large volume contracts with external service providers including medical writers, medical marketing agencies, academic labs, CRO’s, CDMO’s, core facilities, and contract analytical testing labs. I enjoy learning about and developing new technologies with the concept of faster, cheaper, better tools and technology to advance therapeutics for better patient options and outcomes.
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Founder And OwnerOnecellbio LlcLafayette, Ca, Us
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Cso/Coo & Co-FounderUpstart Science Jan 2024 - PresentAt Upstart Science, we are focused on revolutionizing the design and manufacture of biologic medicines. Our innovative solutions to fundamental issues with current biologics will pave the way for a revolution in antimicrobial and therapeutic development. We aim to accelerate the development of life-saving treatments and ensure they are accessible to those in need, thus making a significant impact on global health outcomes. -
Head, Cmc Process Development & ManufacturingImmunova Sep 2023 - Present -
Founder/OwnerOnecellbio Llc Feb 2023 - PresentOneCellBio is a consultancy company focusing on analytical technology, life sciences, CMC, and biotechnology including synthetic biology and pharmaceuticals.
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Head Of ScienceBetteromics Jan 2024 - Dec 2024Redwood City, California, Us -
Co-FounderCoagulant Therapeutics, Inc. Feb 2019 - Jan 2024 -
Vp, Process Development & ManufacturingCoagulant Therapeutics, Inc. Oct 2019 - Dec 2021Reporting to the CEO, I was responsible for managing the biological process development and manufacturing in support of the research and clinical development programs. I was program lead for CT-001, an engineered biologic for acute bleeding indications, and I was responsible for managing the cross-functional team including pre-clinical research, CMC, clinical development, quality, regulatory affairs, and business development/marketing. I was a member of the Executive Committee.
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Svp R&DMission Bio Dec 2021 - Aug 2023South San Francisco, California, UsReporting to the CEO, I was responsible for leading research and development teams for technical development of new products and improvements for existing products. -
Vp Biologics And Co-FounderGladiator Biosciences, Inc. Aug 2017 - Sep 2021Reporting to the CEO, I was responsible for managing the small molecule and biological process development and manufacturing in support of the research and clinical discovery programs. This included the design and production of proteins, fusion proteins, conjugates, linkers and SMOL drug payloads.
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Strategic Advisor To Chief Executive OfficerIntabio Feb 2020 - Jan 2021Supported the CEO and CSO for transition of the company for a successful acquisition by SCIEX at the end of 2020. My role was advisory as well as to create and present scientific applications to potential investors as well as early adopter customers.
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Director, Global Medical Affairs Operational Excellence And Communications, HematologyBayer Consumer Care Ag Jan 2019 - Oct 2019Reporting to the VP of Global Medical Affairs Hematology, I was responsible for managing Operations and Communications, including scientific publication strategy and the Global Medical Team strategy in Hematology. I was responsible for managing the team for day-to-day operations, internal and external budgets, associated contracts (HCP, agencies, etc.), and innovation programs.
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Director, Late Stage Development Projects, Global Biological Development, Bayer Healthcare LlcBayer Pharmaceuticals Jan 2006 - Dec 2018Leverkusen, North Rhine-Westphalia, DeReporting to the VP of Biological Development, I was responsible for managing Global CMC program development teams for hemophilia biologic therapeutics (DS and DP). I was responsible for day-to-day operations, internal and external development timelines, deliverables, resources, budgets, associated contracts (CMO’s, CRO’s), and licensing arrangements. -
Director, Quality Control & Technical OperationsGenomic Health, Inc. 2004 - 2006Redwood City, Ca, Us -
Sr. Director, Reagents & ManufacturingCell Biosciences, Inc. (Now Protein Simple) 2003 - 2004
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Sr. Manager, OligonucleotidesCelera Diagnostcs 2002 - 2003
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Sr. Manager, Consumables Development & ManufacturingApplied Biosystems 2000 - 2002Waltham, Ma, Us -
Associate Director, Technical OperationsBayer Diagnostics 1997 - 2000New York, Us -
Manager, Application DevelopmentHoefer Pharmacia Biotech 1995 - 1997
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Scientist IiChiron Corporation 1993 - 1995Emeryville, California, Us
John Teare Skills
John Teare Education Details
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Washington University In St. LouisBiology/Chemistry -
Saint Louis University School Of MedicineBiochemistry
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The University Of AlabamaMicrobiology
Frequently Asked Questions about John Teare
What company does John Teare work for?
John Teare works for Onecellbio Llc
What is John Teare's role at the current company?
John Teare's current role is Founder and Owner.
What is John Teare's email address?
John Teare's email address is jo****@****ast.net
What is John Teare's direct phone number?
John Teare's direct phone number is +171668*****
What schools did John Teare attend?
John Teare attended Washington University In St. Louis, Saint Louis University School Of Medicine, The University Of Alabama.
What skills is John Teare known for?
John Teare has skills like Biotechnology, Life Sciences, Technology Transfer, Biopharmaceuticals, Fda, Analytical Chemistry, Analytical Biochemistry, Analytical Method Validation, Management Contracts, Contract Manufacturing, Hplc, Lifesciences.
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