Jennifer Painter Email and Phone Number
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Dedicated, high energy professional with a track record of accomplishments across 19 years in pharma, combination products, device and diagnostics sectors, with responsibilities spanning basic research through project management of RUO, IUO and IVD products across multiple technology platforms. Proven experience in global team leadership, and cGLP, cGMP, CFR and ISO requirements and state CLIA/CAP guidelines for 510(k) and IVD products. Key strengths include leadership and communication skills, project management (including FPx and Performance Excellence Green Belt), risk management, technology transfer, attention to detail and global mindset.Core competencies: Design Controls, Project Management, Quality Systems, Medical/Technical Writing, Global Teams, GMP, FPX, Technology Transfer, Assay Development, Pilot Manufacturing, Verification, Validation, Process Excellence, FPx, IVD/IUO/RUO Diagnostics Development, PMA/510K/CE support, supplier audits, SME (ISO/FDA), Quality, Regulatory , Molecular and Cellular Assay Development, Biologics
Johnson & Johnson Innovative Medicine
View- Website:
- genmab.com
- Employees:
- 799
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Associate Director, Clinical DiagnosticsJohnson & Johnson Innovative MedicinePhiladelphia, Pa, Us
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Associate Director, Companion DxGenmab Oct 2022 - PresentPrinceton, New Jersey, United States -
Quality Lead - Partner ProjectsBiocartis Jul 2021 - Oct 2022Represent the Quality Organization in Business Area External Partner projects spanning infectious disease and oncology projects.Accountable for financial & operational perspectives, compliance (including Quality Agreements, IVDR Distribution, Supplier Management, QMS, ISO13485 and 21 CRF Part 820) resource management. -
Site Quality Manager, Us R&DBiocartis Mar 2018 - Oct 2022Raritan, NjResponsible for the establishment of the Biocartis US QMS and integration of the US R&D organization into Biocartis from Janseen Diagnostics. I currently cover the Quality role for all of Biocartis US, including all CAPA, NCRs, Procurement, R&D, Sales and Servicing, as well as supporting global improvement projects and compliance to ISO13485 standards.Biocartis is an innovative commercial stage molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. The Company’s proprietary MDx Idylla™ platform is a fully automated, real time system which offers accurate, highly-reliable molecular information from any biological sample in virtually any setting. Idylla™ addresses the growing demand for personalized medicine by allowing fast and effective treatment selection and treatment progress monitoring.
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Verification & Validation Team LeaderJanssen Diagnostics Oct 2014 - Mar 2018Raritan, New JerseyResponsible for product design, execution, multi-site implementation and life-cycle management for all release methods, reagent formulations and process documentation and global process/product control strategies for multiple CE, 510(k) and IVD products spanning infectious disease (viral), oncology and genotyping. Led highly matrixed teams to on-time closures for all design and product development phases for each project. Risk assessment owner for process and product risk, as well as lead R&D interface with Quality for implementation of the customer Idylla™ IFV-RSV Assay complaint handling and CAPA processes. Managed highly-matrixed, cross-disiplinary team to complete the project.
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Technical Leader – Combination Product Remediation (1Yr Rotation)Janssen Inc. Jan 2017 - Jan 2018Device Coe, Technical OperationsLed Global, Cross-functional teams to develop and optimize Device Master Records (DMRs) programs to ensure compliance with the FDA Combination Product Regulations and in alignment with, and support of, the Janssen Global Combination Product Remediation program. Shaped and standardized global processes relating DMRS at Local Operating Companies, Distribution and Warehousing of Janssen Combination Products. Shaped and standardized new SOPs and WIs for the development of Global Janssen programs related to Control Strategies, Control Plans for Combination Products, Mold Remediation efforts and the related CTQ/CTA analysis. Core competencies: Design Controls, Project Management, Global Teams, GMP, FPX, Quality, Life Cycle Management -
Senior ScientistOrtho Clinical Diagnostics Jan 2009 - Oct 2014Raritan, NjTeam leader for the development of sample purification and/or detection methods for multiple assays under development, including the integration of bench chemistries onto the prototype Idylla instrument, leading to the completion of the first fully integrated cartridge on the Idylla system for J&J. Gained experience in assay architecture, system architecture, regulatory knowledge of 510K devices and global collaboration. -
Senior ScientistVeridex, Llc (Johnson & Johnson) Apr 2003 - Dec 2008Raritan, New JerseyProgressed from Scientist I to Senior Scientist, representing R&D on the Software Core Team and served as Project Technical Lead for the BLN Software program as well as leading lab PCR assay development for GeneSearch™ BLN (IVD) assay. Successfully designed the final protocol PCR protocols allowing 40cycle RT-PCR to be completed in <17 minutes, exceeding marketing requirements. Experienced in test method development for antibody and enzyme purity and identification.
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Senior Associate ScientistPraelux,Llc (Ge Healthcare) Jun 1999 - Apr 2003
Jennifer Painter Skills
Jennifer Painter Education Details
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Molecular Biology -
Masters Certificate, Program Management -
Biotechnology
Frequently Asked Questions about Jennifer Painter
What company does Jennifer Painter work for?
Jennifer Painter works for Johnson & Johnson Innovative Medicine
What is Jennifer Painter's role at the current company?
Jennifer Painter's current role is Associate Director, Clinical Diagnostics.
What is Jennifer Painter's email address?
Jennifer Painter's email address is jp****@****tis.com
What schools did Jennifer Painter attend?
Jennifer Painter attended Lehigh University, Villanova University, Rochester Institute Of Technology.
What skills is Jennifer Painter known for?
Jennifer Painter has skills like Assay Development, Biotechnology, Fda, Cell Biology, R&d, Medical Devices, Validation, Biochemistry, Elisa, Molecular Biology, Gmp, Iso 13485.
Who are Jennifer Painter's colleagues?
Jennifer Painter's colleagues are Ratna Eka Raharto, Elles S., Patrick De Ritter, Crystal Szobonya, Lucas Bjørling, Sophie Stolzenbach, Jack Pieters.
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