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Vice President, Manufacturing - Madison, United States - eGenesis
Description
COMPANY MISSIONAt eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.
POSITION SUMMARYeGenesis is seeking an experienced and innovative Vice President of Manufacturing to provide leadership across eGenesis's manufacturing teams, including Donor Production and Embryo Production.
You will execute a strategic vision for the production of eGenesis's genetically modified porcine donors to support preclinical and clinical studies, as well as drive strategic and tactical efforts to produce eGenesis's drug product at scale.
In this position, you will bring strong manufacturing experience to lead a growing team across four sites that is focused on all manufacturing capabilities including scaling production, donor cloning and breeding, donor health and welfare, product characterization and release and logistics of donor and organ procurement.
The successful candidate thrives in rapidly growing organizations and can bring clarity and direction to a multi-faceted, complex process. You will build manufacturing through key development milestones and decision points.The ideal candidate demonstrates strength in communication and team leadership in a role that is broadly engaged across the organization.
PRIMARY RESPONSIBILITIESProvide overall leadership and strategic vision for the production of eGenesis genetically modified porcine donors to support preclinical and clinical studiesDevelop and execute strategic plan to support launch at scale, including defining the strategic supply chain plan to produce, procure and deliver drug productPrepare and present routine manufacturing and supply chain reports to Executive Leadership Team and key stakeholders, including current production and future forecastEvaluate and centralize porcine production database and donor trackingProvide strategic recommendations to support continued supply on drug product and enable rapid scale up of production Proactively identify risks in manufacturing timelines in regard to corporate milestones and work closely with Executive Leadership Team and functional leaders to mitigate program impactsFacilitate effective, data-driven decision-making to support success eGenesis' overall portfolio including scenario planning, highlighting all potential downstream impacts of strategic decisions, including resource allocation, team capacity and risksManage eGenesis' current Donor Production and Embryo Production teams, which are cross-disciplinary groups including donor cloning, breeding and husbandry, supply chain, and business operations.
Develop and coordinate ongoing resource planning for manufacturing, including owning shared responsibility for recruiting and retaining top donor production team members to maintain and build eGenesis' cultureDevelop strong collaboration with internal and external stakeholders including Quality, Regulatory Affairs, Analytical Development, project teams, research organizations, regulatory authorities, and other key stakeholdersMaintain high quality standards and quality control for donor production, as well as identify best practices and areas for process improvementBASIC QUALIFICATIONSAt least 20 years of industry experience, with a minimum of 10 years focused in strategic manufacturing in a fast-paced, regulated biotech environmentBackground in veterinary sciences, animal production, drug substance and drug product production (CMC), and/or related area is preferredStrong understanding of overall drug development and production strategies, spanning across all critical product development disciplines (nonclinical, clinical, CMC, Regulatory Affairs, Quality, commercial strategy and development)Demonstrated track record executing a product production strategy to support drug candidate selection, preparation for first-in-human studies, and assistance through clinical development, product registration, and post-marketing research studiesAbility to operate effectively within an innovative and science-driven company environment; instinct to proactively engage others, ability to inspire others, driven and hands-on with unquestionable integrity Strong understanding of a discovery environment and ability to lead teams with both discovery and production backgroundsAbility to travel 20% of the time to Indiana and Massachusetts locations
