Senior Manager, QC Cell Therapy Analytics

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:

The Sr. Manager of Quality Control is responsible for overseeing the QC Analytics – Cell Therapy laboratory, testing and staff at our BaseCamp facility in Waltham. This position will work with Quality management and Analytical Development to implement the laboratory systems and testing strategies for ElevateBio’s cell and gene therapy programs. Additionally, the Sr. Manager will monitor laboratory metrics and review and approve excursions associated with routine laboratory operations.

Here’s What You’ll Do:

• Assist in development, implementation, and maintenance of laboratory systems in compliance with applicable GMP practices and regulations.
• Draft, review and approve SOPs, test methods, specifications and associated protocols and reports.
• Qualify/Validate test methods developed by or in conjunction with Analytical Development.
• Transfer methods from external clients.
• Collaborate with clients and ancillary internal teams to support tech transfer and routine testing processes.
• Oversee daily laboratory operations, including; equipment maintenance and calibration, routine analytical testing and results reporting in LIMS.
• Work cross functionally with other QC groups (i.e. QC Microbiology, QC Raw Materials, QC Analytics (Viral Vector) and QC Outsourcing) to ensure all testing is initiated and completed within established timelines.
• Review and approve analytical testing excursions, including; deviations, CAPAs and OOSs.
• Develop metrics to evaluate and monitor the performance of the QC cellular analytics laboratory.
• Support inspections and facility audits.
• Hire, train, and mentor laboratory staff.

Requirements:

• B.S. or M.S. in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 8-10 years of experience in GMP QC laboratory setting.
• Significant experience with gene and cell therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and cell-based assays).
• Ability to communicate and work independently with scientific/technical personnel.
• Strong knowledge of GMPs, SOPs, and Quality system processes.
• Excellent organizational skills.
• Experience performing laboratory investigations.
• Experience in cell and gene therapy manufacturing environment is a plus.
• Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.

 

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 qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.