Senior Manager, Analytical Tech Transfer

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power cell and gene therapy processes, programs, and companies to their full potential.

The Role:
ElevateBio is looking for a Senior Manager, reporting to the Head of Analytics, to oversee the qualification, and transfer of analytical methods from the Analytical Development teams to ElevateBio QC or external GMP labs. The position will work closely with the AD SMEs and the QC team and will provide recommendations for method improvements and lifecycle management of assays. This is a highly visible, cross-functional leadership role that will have the opportunity to impact numerous Cell and Gene therapy programs of ElevateBio.  

Here’s What You’ll Do:

• Participate, lead, and manage the qualification of analytical methods in close collaboration with the Elevatebio QC team. Provide guidance in designing and execution of method qualifications per ICH and regulatory guidelines.
• Provide leadership and management during the transfer of analytical methods from the Analytical Development team to Elevatebio QC lab or external vendors.
• Collaborate with AD SMEs and the QC team to generate and approve protocols, reports, other technical documents required for the qualification and transfer of analytical methods.
• Communicate and coordinate discussion between key stakeholders to work through potential challenges, troubleshooting, during qualification and method transfer activities.
• Provide necessary support during assay development as required. Provide expertise for improving existing assays, and implementation of new ideas and technologies.
• Provide support during investigations of relevant deviation incidents related to assay qualification or validation efforts.
• Analyze, interpret, and present data during team meetings and discussions.
• Form active collaborations and communicate with teams within Analytical Development, Quality, and other functions as well as external vendors.

Requirements:

• BS or MS in cell biology, molecular biology, biochemistry, or related sciences with a minimum of 8 years (MS) or 10 years (BS) of relevant and progressive experience in a Biotech setting.
• Significant experience and track record of development/ qualification, and transfer of analytical methods to QC GMP labs is required. Knowledge of ICH/ regulatory guidelines for method qualification is required.
• Experience or working knowledge of a variety of assays/ technologies, e.g., cell-based potency bioassays, ELISA, MSD, ddPCR, qPCR, HPLC, etc. is required.
• Extensive knowledge and strong scientific background related to CGT products and viral vectors (e.g., Lentivirus, AAV) is a plus.
• Experience in a lab based supervisory or leadership position is a plus.
• Must have strong writing, and communication skills. Must have prior experience of authoring and reviewing protocols and technical reports.
• Organization skills, and prior experience of leading/ mentoring scientists and associates is required.
• Prior experience of regulatory filings is preferred.

Why Join ElevateBio?

ElevateBio is accelerating access to the cutting-edge technologies and expertise that will change the future of medicine. Our ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene-editing platform; a proprietary induced pluripotent stem cell (iPSC) platform, and an RNA, cell, protein, and vector engineering platform – with BaseCamp®, our end-to-end genetic medicine cGMP manufacturing and process development business, to power the discovery and development of advanced therapeutics.

With these leading-edge platforms and capabilities, we are enabling a broad breadth of biopharmaceutical companies in the development of their novel cell and gene therapies while also building our own innovative pipeline of cellular, genetic, and regenerative medicines. Together, we aim to be the dominant engine inside the world’s greatest scientific advancements harnessing human cells and genes to alter disease.

Our Mission: 
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

Our Vision: 
We seek to be the world’s most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated. 

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and