Elevatebio
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Manage the Quality Systems and Audit and Compliance program at ElevateBio, oversee internal and external audits, ensure compliance with regulations, and support training and development of audit team members.
The Senior Manager in CMC Operations and Program Management will lead the planning and execution of process performance qualification (PPQ) and commercial readiness for genomic medicines, managing cross-functional teams to ensure timelines and regulatory compliance are met, while overseeing batch execution and preparation for regulatory inspections.
The Tax Director at ElevateBio will spearhead comprehensive tax planning strategies, manage relationships with tax advisors, ensure compliance with tax filings, oversee audits, and drive system improvements for efficiency. They will also support the Finance team with cash forecasting and manage all tax-related projects.
The Technical Writer will create and manage quality and technical documentation, including SOPs, to support Commercial Readiness initiatives. Responsibilities include advising on Operational Excellence programs, conducting training, and ensuring project deliverables meet milestones effectively.
The Process Engineer II will provide technical support for manufacturing operations, assist with equipment lifecycle management and troubleshooting at the BaseCamp facility, and collaborate with cross-functional teams to ensure compliance with GMP standards.
The Senior Associate Bioinformatics Data Engineer will be responsible for integrating data across multiple software platforms, ensuring data integrity, automating data workflows, and analyzing high-throughput sequencing data. Collaboration with scientists and the internal bioinformatics team is critical for delivering clear analysis and visuals.
The Senior Quality Engineer will lead QA oversight for technology transfer activities in cell and gene therapy, ensuring cGMP compliance and supporting process validation, risk assessments, and technology transitions from clinical to commercial manufacturing. Responsibilities include managing and reviewing documentation, investigating discrepancies, and promoting continuous improvement within the QA team.