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 genetic medicines processes, programs, and companies to their full potential.
The Role:
ElevateBio is looking for an outstanding candidate for a leadership position to join our Manufacturing Science and Technology Organization in support of our growing client portfolio for genomic medicines. This role is responsible for leading process performance qualification (PPQ, process validation) and commercial readiness activities in support of advanced therapies. This leader will lay the technical foundation for the process validation program while building a team of engineers to support commercial manufacturing. Candidates should have extensive experience with biologics/CGT manufacturing in a commercial GMP setting, PPQ planning and execution, supporting regulatory filing and inspections, hiring and managing staff and working within highly matrixed cross-functional teams.
Here’s What You’ll Do:
- Lead and manage commercial readiness and PPQ activities ensuring compliance with regulatory standards and company policies.
- Design and establish process validation framework including creation of policies and SOPs in collaboration with key stakeholders such as quality assurance.
- Collaborate with cross-functional teams, including external client teams as well as internal Quality, Regulatory Affairs, and Manufacturing, to ensure seamless execution of PPQ activities.
- Oversee the preparation and review of PPQ protocols, reports, and related documentation.
- Oversee the design and execution of supporting BLA enabling studies such as filter validation, shipping validation, aseptic process validation etc
- Establish and oversee continued process verification (CPV) program using state of the art digital technologies
- Support raw material and consumable program as a process SME
- Establish and support life cycle management program for post approval changes.
- Ensure successful delivery of commercial batches in partnership with Manufacturing, Supply Chain, Quality and supporting functions by providing technical oversight of manufacturing batch execution, deviation management, troubleshooting, and batch disposition.
- Partner with CMC Regulatory and SMEs to develop content for regulatory submissions (INDs, BLAs, DMFs etc.)
- Actively support PAI readiness and regulatory inspections of BaseCamp Waltham site.
- Build and grow a team of talented engineers or scientists to support PPQ and future commercial batches.
Requirements:
- Minimum Bachelor’s Degree in Engineering, Science, or related field. Master’s or Ph.D strongly preferred.
- At least 12 years of experience in a MSAT, Process Development or GMP environment supporting complex biologics products. Experience in autologous gene or cell therapy a plus.
- At least 5 years of managerial experience in hiring and managing direct reports.
- Extensive experience in leading process validation and commercial manufacturing support.
- Demonstrated ability and strength in leading cross-functional technical teams within a matrixed organization.
- A strong technical leader who can problem solve while balancing business needs with technical risks within a regulated environment.
- Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ICH guidelines).
- Prior experience with regulatory submission and regulatory inspection is strongly preferred
- Experience with digital tools used in manufacturing operation (eg. eBR, SAP) and fundamental understanding of data and statistical analysis.
- Excellent project management, organizational, and communication skills including communication with senior leadership and external stakeholders.
- Experience working within a contract manufacturing or client service organization strongly preferred.
Why Join ElevateBio?
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
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.
What We Do
ElevateBio is a technology driven company powering transformative cell and gene therapies today and for many decades to come.
The company has assembled industry-leading talent, built world-class facilities, and integrated diverse technology platforms necessary for rapid innovation and commercialization of cell, gene, and regenerative therapies. The company has built an initial technology stack, including gene editing, induced pluripotent stem cells, and protein, viral, and cellular engineering. At the center of the business model is ElevateBio BaseCamp, a centralized R&D and manufacturing company that offers research and development (R&D), process development (PD), and Current Good Manufacturing Practice (CGMP) manufacturing capabilities. The company is focused on increasing long-term collaborations with industry partners while also continuing to develop its own highly innovative cell and gene therapies. ElevateBio's team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare.
ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass.
