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The Senior Manager of Operational Technology will oversee technical operations and infrastructure in an industrial and cell therapy lab, ensuring 24x7 operational support. Responsibilities include managing OT systems, developing implementation plans, ensuring compliance with security best practices, troubleshooting production issues, and delivering training for OT staff, while interacting with senior leadership and business functions to align priorities.
Seeking a Senior Analytical Transfer Specialist to lead analytical method transfers, evaluation, and support for cell therapy QC operations. Responsibilities include authoring procedures, contributing to regulatory submissions, and providing technical leadership. Requires a Bachelor's degree and 4+ years of experience in biologics/gene therapy with knowledge of QC principles and relevant analytical methods.
Seeking a Senior Process Engineer to contribute to the development of an advanced cell therapy manufacturing platform. Responsibilities include technology transfer, process development, compliance, scalability, and driving process automation solutions. Must have 5+ years of experience in biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy.
Seeking a VP, CMC Process Sciences to oversee establishment and execution of CMC development plans for cell and gene therapy products. Responsible for providing CMC leadership, collaborating with stakeholders, and driving effective communication and coordination across functional groups.
The VP of Finance will lead operational and financial planning cycles, oversee FP&A activities such as forecasting and budgeting, provide insights on project profitability, conduct internal cash flow analysis, and prepare financial presentations for stakeholders.
Seeking an experienced Senior Data Engineer to lead the design, development, and management of scalable data pipelines and architecture for a cell therapy manufacturing platform. Responsibilities include data pipeline implementation, collaboration with cross-functional teams, data preprocessing for machine learning models, and documentation of processes. Requirements include a Bachelor's or Master's degree in Computer Science, 6+ years of data engineering experience, proficiency in Azure services, programming skills in Python or C#, and experience in data visualization tools and data governance.
The Manager of Analytical Operations will oversee a team of scientists and analysts, manage assay execution and data analysis, ensure compliance with regulatory standards, and troubleshoot operational issues. Responsibilities include method transfer, team management, and aiding in regulatory submissions.
The CMC Program Manager at Cellares is responsible for managing project timelines and coordinating activities related to cell therapy manufacturing, acting as a liaison between multiple cross-functional teams. Responsibilities include budget management, risk mitigation, regulatory filings support, and ensuring customer satisfaction through effective communication and problem-solving.
The Senior Process Engineer will lead technology transfer activities for cGMP manufacturing, focusing on process automation, compliance, and scalability. Responsibilities include developing project plans, supporting late-stage process development, defining user requirements for equipment, conducting root cause analyses, and collaborating with stakeholders. This role requires expertise in technology transfer and manufacturing science.
The Senior Client Systems Engineer will design, upgrade, and maintain client systems while implementing new systems and providing training to team members. Responsibilities include resolving end user help requests, managing IT systems like Intune and Zoom, and providing support for desktop and mobile devices. They will also manage company assets and collaborate with the network team.
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