That first job was issued as of yesterday and this job issued 25 days ago...
MessagingDirector Of OperationsImagion Biosystems, IncSan Diego, California, United StatesPosted 25 days agoSaveSave Easy applyJob descriptionJob titleDirector of OperationsReports toCFOFLSA StatusFull Time (Non-Exempt)Job OverviewImagion Biosystems, Inc. is looking for a motivated and experienced manufacturing and operations professional to join our growing management team to establish robust manufacturing capabilities to produce the metallic nanoparticles used in our proprietary imaging technology and supplied to 3rd parties for biomedical applications. The Director of Operations will be the senior representative for the company’s manufacturing operations and facilities management. The Director of Operations will ensure nanoparticle products are transitioned from R&D into production including those products outsourced to Contract Manufacturers (CMOs). Products will include research-grade (RUO) products as well as FDA and ISO 13485/MDD compliant products, including OEM or 3rd party products. Candidates must have experience with good manufacturing practices (cGMP) of regulated medical devices and/or pharmaceutical product. The ideal candidate will be self-directed, deadline-driven, detail-oriented, and comfortable working in a fast-paced interdisciplinary team environment.Primary Duties and ResponsibilitiesThe Director of Operations will be required to:Oversee all operational activities related to manufacturing, supply chain, and facilities maintenance to support nanoparticle production.Develop and build from the ground up the business practices and infrastructure necessary to support the manufacturing of products being used in clinical development and those commercialized directly or sold to 3rd parties using a combination of in-house production and Contract Manufacturers.Hire, train, and manage manufacturing personnel, such as technicians and engineers, as needed to support the business plan.Partner with product development and clinical management to execute robust manufacturing processes to ensure products meet specifications/requirements as they transition from R&D into translational, clinical and commercial phases.Manage inventories, including raw materials, Work in Process (WIP), and finished goods.Ensure the Company is prepared for compliance with the U.S. FDA Code of Federal Regulations, the EU Directives, EN 13485, and other International Quality Standards and local requirements as needed.Work with team members and third-party suppliers to establish and maintain the appropriate product documents, needed for the medical device or drug product regulatory filings.Establish a manufacturing operation that strives for continuous improvement and delivery of quality product to drive the growth of the business.Manage all aspects of maintaining the Company’s San Diego facility.
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