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include but are not limited to Lead the Novavax Market Access Strategy team to build and deliver upon well integrated winning market access strategies in preparation to launch the vaccines pipeline, starting with the highly visible COVID 19 Vaccine. This will require the definition of new capabilities and new channel partnerships and the development of those capabilities and relationships. The dev
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include but are not limited to Establish Governance and Build Knowledge Facilitate an information security and compliance governance structure through the implementation of a governance program. Provide regular reporting on the current status of the information security and compliance program to senior business leaders and the board of directors as part of a strategic enterprise risk management pr
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include but are not limited to Assist in establishing global sales agreements and related dose forecasting. Develop compliance policies and SOPs with key departments. Establishment of master data management systems and process. Market analytics, customer targeting, sales force size and structure planning, data capture and reporting, forecasting and goal setting, incentive compensation planning, ,
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include but are not limited to Write first draft of technical reports, regulatory submissions, CMC sections etc. after reviewing and analyzing technical data with subject matter experts Assist team and subject matter experts in the organization and preparation of technical data and documents for assay development, process development and optimization, and validation Write SOPs. Compile/analyze da
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include, but not limited to Responsibility for drug substance technology transfer activities from preclinical development through commercial supply Identification, selection and management of Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of DS in support of ongoing clinical programs Delivery of robust, scalable and cost effective
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include, but not limited to Responsibility for drug substance technology transfer activities from preclinical development through commercial supply Identification, selection and management of Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of DS in support of ongoing clinical programs Delivery of robust, scalable and cost effective
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include, but not limited to Responsibility for drug substance technology transfer activities from preclinical development through commercial supply Identification, selection and management of Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of DS in support of ongoing clinical programs Delivery of robust, scalable and cost effective
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include but are not limited to Design, definition, and execution of scientific formulation activities for preclinical and early clinical studies for the formulation development of solid and liquid drug product presentations. Scientific Activities including, but not limited to Design and execute Quality by Design (QbD) and Design of Experiment (DOE) principles in drug product and process developmen
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include but are not limited to Transfer and implement the proposed process to demonstrate it is robust, high purity/yield, economic and scalable for clinical stage manufacturing of nanoparticle vaccine and other biologic product candidates, with particular attention to regulatory expectations on product quality and also on suitability and sourcing of raw materials, reagents, and separation materia
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include but are not limited to Lead a team to develop, qualify, and validate methods for process related impurities (e.g. DNA, RNA, virus, and retrovirus), contaminants (e.g (e.g. adventitious agents), and baculovirus particles of protein vaccine products. Develop control strategy for process related impurities of expression system for vaccine products. Manage resource to support Process Developme
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include but are not limited to Develop, qualify and validate HPLC assays for purity of protein nanoparticle vaccines. Develop and qualify assays to quantitate proteins in protein nanoparticle vaccines. Write SOP's, development report and assay qualification/validation report. Perform in process testing to support process development activities. Perform tech transfer to Quality Control and other gr
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02 Oct 2020 to 14 Nov 2020 (EST) Quality Assurance Gaithersburg, MD, USA Full Time Exempt Novavax, Inc. (Nasdaq NVAX) is a late stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX CoV2373, its vaccine candidate against
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include but are not limited to Responsible for procurement activities including purchase order (PO) creation and management, cost analysis, inventory and vendor management in accordance with Novavax operating policies and procedures. Analyze demand and usage of various materials including critical supplies, clinical materials, components and consumables. Develop and manage relationships with key s
Posted 1 day ago
include, but are not limited to Responsible for drug product technology transfer activities from preclinical development through commercial supply Identify, select and manage of Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of DP in support of ongoing clinical programs Deliver robust, scalable and cost effective manufacturing pro
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include but are not limited to Provide overall management and oversight of outsourcing and budgeting activities within assigned projects Manage strategic and/or preferred provider relationships, including ongoing governance activities and monitoring of vendor performance. Take a lead role in key sourcing, business process, and/or cost savings initiatives. Lead project team activities related to co
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