Search the 15 jobs at Elevatebio

The Manager, CMC Operations and Program Management will lead activities related to process performance qualification and commercial readiness for genomic therapies. Responsibilities include managing timelines, overseeing cross-functional teams, ensuring compliance with regulatory standards, and supporting the delivery of commercial batches and regulatory submissions.

The Technical Writer will develop and manage quality and technical documentation for cross-functional teams, focusing on Standard Operating Procedures and support for commercialization efforts at ElevateBio. They will also facilitate technical training and ensure project milestones are met effectively.

The Tax Director will develop and implement tax planning strategies, manage relationships with tax advisors, oversee tax filings, monitor tax law changes, ensure compliance with GAAP, manage audits and tax projects, and assist the Finance team with cash forecasting and management.

The QC Technical Writer II will support Lab Compliance and Continuous Improvements by completing quality event records, conducting root cause investigations, and assisting with CAPA and Change Control processes. This role requires collaboration with various QC and analytical teams and involves training laboratory staff.

The Director of MSAT at ElevateBio will lead process performance qualification and commercial readiness activities for genomic therapies. Responsibilities include overseeing compliance with regulatory standards, establishing process validation frameworks, collaborating with cross-functional teams, and managing a team of engineers. The role focuses on delivering commercial batches and supporting regulatory submissions.

The Associate II in Analytical Testing Core will perform non-GMP assays to support research and manufacturing efforts. Responsibilities include managing sample receipt, executing tests, drafting SOPs, maintaining inventory, and ensuring timely data reporting.

As a Process Engineer Contractor at ElevateBio, you will provide technical support for GMP manufacturing, technology transfers, and validation projects. Key responsibilities include authoring technical documentation, conducting root cause analysis, supporting process validation, and collaborating across functions to enhance manufacturing processes.

The Senior MES Engineer will manage and optimize Manufacturing Execution Systems, leading a team of engineers, handling multiple tech transfer projects, and ensuring smooth transitions between MES systems. Responsibilities include project planning, developing standards for documentation, and supporting system upgrades. The role demands strong project management skills and GxP manufacturing experience.

The Process Engineer II will provide technical support and troubleshooting for manufacturing processes in a GMP biotech facility. Responsibilities include managing equipment lifecycle, resolving technical issues, and collaborating with cross-functional teams for process optimization and compliance with regulatory standards.

As a QC Specialist I at ElevateBio, you will support QC analytical activities and logistics, review assay protocols, analyze data from contract labs, manage sample submissions, and handle stability data and reports.

The Director of QA Operations leads Quality Assurance oversight for cell and gene therapy manufacturing at ElevateBio's BaseCamp facility. This role includes managing a QA team, ensuring compliance with cGMP regulations, implementing quality processes, and collaborating with various departments to enhance product quality and manufacturing efficiency.

The Principal Associate Scientist will support the development and execution of molecular assays and collaborate closely with various teams. Responsibilities include optimizing methods, generating protocol documents, troubleshooting, and participating in the lifecycle management of assays, as well as analyzing and presenting data.

Manage the Quality Systems, Audit, and Compliance program to ensure compliance with internal policies, regulations, and guidelines. Lead internal and external audit processes, coach auditees, monitor CAPAs, and drive continuous improvement. Support client audits, compile quality metrics, and promote a Quality Culture.

As Site Head for ElevateBio’s BaseCamp Pittsburgh, you will lead operations, develop talent management plans, recruit top talent, manage project teams, ensure compliance, and foster collaboration for successful operational startup by early 2027.

The Senior Manager, CQV will oversee the commissioning, qualification, and validation processes for ElevateBio's new cell and gene therapy manufacturing facility. Responsibilities include preparing validation documentation, leading validation activities, managing external contractors, and ensuring compliance with GMP regulations, while coordinating with various engineering and operational teams.