Rolf Jansen Email and Phone Number
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A proven team leader interested in the development of new and novel pharmaceutical products with a history of successful controlled release oral, transdermal, polymeric and combination product development, commercialization and launch of US and ROW products. Specializing in process design and optimization, GMP manufacturing, CDO/CMO management, manufacturing scale-up and transfer, continuous improvement, and strategic oversight of technical operations.
Eyconis, Inc
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Vice President Operations And Program ManagementEyconis, Inc Mar 2024 - PresentRedwood City, California, Us
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Sr. Director Cmc Product DevelopmentAscendis Pharma Oct 2022 - Apr 2024Hellerup, Capital Region Of Denmark, DkDirected a team to manufacture phase 2 clinical trial materials for oncology program, complete phase 2 development and prepare for phase 3 scale up with manufacturers in the US, EU, and China -
Contract SpecialistMultiple Companies Apr 2021 - Apr 2024Us -
Vice President Of Development And ManufacturingMedicines360 May 2020 - Mar 2021San Francisco, California, Us -
Vice President Of Technical OperationsRelypsa Mar 2016 - Dec 2019Responsible for the oversight of commercial manufacturing at contract suppliers including strategic management and development of raw material suppliers, API production planning, clinical and commercial product manufacturing of Veltassa® for the US and expanding global market, post market product development, cost reduction and budget planning, contract negotiation, support of global regulatory submissions, post launch product monitoring, complaint investigations and mitigation.
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Associate Director Of Product DevelopmentKindredbio Nov 2014 - Jan 2016Performed gap analysis of lead program, prepared technical summary and met with FDA advisory board to get concurrence on mitigation strategies. Coordinated development and commercialization CMO’s to compile development history and authored product development report and all technical sections of successful CMC submission for controlled release oral product.
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Director Of Process Engineering / Product DevelopmentMedicines360 Oct 2010 - May 2014San Francisco, California, UsLed development of intrauterine drug/device systems and manufacturing process scale up at multiple CMO's. Developed in vitro release rate assay methods and IV/IVC models, proposed process and assay improvements to FDA and successfully completed the NDA filing for Liletta®.
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Director, Process EngineeringCapnia Corporation Jan 2009 - Sep 2009Seattle, Washington, UsDeveloped the API vendor supply chain to enable production and testing of a novel Phase III drug / device product. Conducted on-site manufacturing reviews to identify and coordinate mitigation of EU and US compliance issues with vendor quality and manufacturing systems including documentation, training, material testing, processing, storage, transfer, and validation. -
Associate Director Of R&D OperationsJohnson & Johnson Oct 2006 - Dec 2008Responsible for operation of transdermal and oral development manufacturing plants supporting product development, scale up, and transfer to commercial production.
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Principal Engineer / ManagerJohnson & Johnson Apr 2000 - Oct 2006Responsible for transdermal product engineering development, scale up, and transfer to commercial manufacturing. Developed release model and designed 2nd generation Duragesic® (fentanyl matrix transdermal system), FDA approved this product in 2009.
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Staff EngineerAlza Corporation Apr 1992 - Mar 2000Seattle, Washington, UsDeveloped and characterized manufacturing process for drug / device combination products. Conducted experiments and summarized results in technical reports to justify material variances and process ranges for scale up.
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Research EngineerPerseptive Biosystems Jan 1989 - Sep 1991Responsible for the analytical method development, testing, and production of new chromatography media, columns, and equipment.
Rolf Jansen Skills
Rolf Jansen Education Details
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University Of Massachusetts AmherstChemical Engineering
Frequently Asked Questions about Rolf Jansen
What company does Rolf Jansen work for?
Rolf Jansen works for Eyconis, Inc
What is Rolf Jansen's role at the current company?
Rolf Jansen's current role is Drug development and manufacturing professional. Expert in late stage Drug Development, GMP Manufacturing, and Operations Leadership..
What is Rolf Jansen's email address?
Rolf Jansen's email address is rj****@****360.org
What schools did Rolf Jansen attend?
Rolf Jansen attended University Of Massachusetts Amherst.
What skills is Rolf Jansen known for?
Rolf Jansen has skills like Gmp, Validation, Design Of Experiments, Pharmaceutics, Process Simulation, Process Engineering, Fda, Technology Transfer, Biotechnology, Manufacturing, Pharmaceutical Industry, Product Development.
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