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Serve as Subject Matter Expert on manufacturing of cell culture and cell-based products, supporting development, manufacturing, investigations, process improvements and support regulatory filings, tec...
Build and lead a team of scientists and engineers to support devices and translate business requirements into process changes in support of product and manufacturing strategies...
Ensure ongoing production of timely, quality drug product by leading tech transfer, commercial manufacturing, technical support, and process monitoring/trending activities...
Lead cross functional meetings with Quality, Regulatory, Supply Chain, Process Development, Analytical and Drug Product to build consensus on key issues and facilitate decision making to move the proj...
Qualification of changes to distribution and thermal transport/storage systems and methods for finished drug products; Participating in periodic Business Review Meetings with external packaging partne...
The Director, Operations is responsible for the strategic leadership development and operational planning for multiple facilities within an integrated global supply chain. The Director is responsible...
Arrange and oversee shipments of cell lines, drug substance and associated samples to third party warehouses, CRO and drug product CMOs.
Lead and coordinate resources to ensure quality standards are met and products are delivered on time and within budget.
Determines organizational objectives, interprets company policy and delegates assignments to direct report managers.
Oversee manufacturing of clinical trial material, registration batches, and commercial process validation at contract development and manufacturing organizations (CDMOs)...
Responsible for managing external contract development and manufacturing organizations from process scale-up to commercial manufacturing.
Set-up and execute a comprehensive plan to manage and grow a global team sourcing and category managers to efficiently execute the portfolio strategy and meet key results...
Manage execution of CMC documentation including IND/clinical trial application (CTA), original BLA/marketing authorization application (MAA), or Post Approval Life Cycle, including agency background p...
Communicate operational status regularly to senior management and program teams, as required, at the appropriate level of detail. Communications will be both written documents, and in formal and infor...
Contribute to the design and development of stability programs to support shelf-life and distribution of drug product.
Collaborating with research, process development, and internal/external manufacturing sites to support New Product Introductions, enabling on-time, right-first-time vaccine technology transfers...
Oversee the design, development, and qualification of analytical methods to assess product identity, purity, quality and potency.
The successful candidate will be responsible for the technical oversight and management of early and late stage drug product fill and finish operations, including...
Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data...
Work collaboratively across the IT organization to ensure all technology services needs are identified in a timely way and communicated, planned and budgeted effectively. Must effectively communicat...
Provides expertise and is responsible for vendor selection, management of the manufacturing process, regulatory compliance and selection of any equipment and human resources required to complete the p...
Manage a talented group of Directors, Managers, Engineers, and Team Leads developing Manufacturing and Fulfillment strategies and key supply chain workflows...