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.
ElevateBio is looking for a Cell Therapy Manager, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Manager will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events. This individual will manage a team of QA professionals and engage with other members within operational departments as a Quality partner by providing real-time support to achieve on-time closure of quality records and disposition. A successful candidate in this position has thorough understanding of cGMP, solves problems by applying a combination of best practices and creative solutions, proactively identifies opportunities for new initiatives, and serves as a subject matter expert within Quality related functions.
Here’s What You’ll Do:
- Develop and coach team members for fostering a collaborative environment and enabling performance.
- Ensure timely delivery of final product through performance of disposition activities.
- Serve as Quality Point-of-Contact for a client program.
- Provide on-the-floor QA oversight and support in the GMP cleanroom to ensure compliance to GMP regulations throughout the manufacturing areas.
- Perform receipt and disposition of incoming patient apheresis material.
- Perform issuance verification of production documents and labels, to meet production schedule.
- Ensure products are manufactured in compliance with regulatory and GMP guidelines.
- Ensure all product-related Deviations are initiated, investigated, and resolved.
- Ensure that associated CAPAs are initiated and resolved.
- Perform review of quality records including lab investigations, work orders, and change controls.
- Ownership of quality records such as impact assessments, major deviations, CAPAs and change controls.
- Identify compliance risks and escalate the issues to appropriate levels of management for timely resolution.
- BA/BS degree with 7+ years of experience in a pharmaceutical, biotechnology or biologics operation.
- Experience in Viral Vectors, Cellular and Gene Therapy Products is desired.
- Working knowledge and ability to apply GMPs.
- Strong teamwork and collaborative skills.
- Experience with manufacturing investigations, deviations, and CAPA.
- Experience with change control practices and strategies.
- Strong knowledge with aseptic manufacturing processes is preferred.
- Experience in electronic Enterprise Management systems, Quality Management Systems, Document Management Systems.
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.
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.
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.