Senior Raw Material Specialist, Quality Control
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:
The Senior Raw Material Professional will work cross-functionally with Technical Operations/ Manufacturing Sciences & Technology, Manufacturing, Supply Chain, Quality Control and Quality Assurance to ensure commercial readiness of the Raw Material Program at our Waltham Base Camp facility. Specifically, this position will work to establish control strategies, specifications and testing & inspection procedures for raw materials used to manufacture commercial cell and gene therapy products.
Here’s What You’ll Do:
- Develop and implement efficient, phase-appropriate, risk-based control strategies for raw materials using applicable GMP regulations and compendial monographs for use in commercial manufacturing.
- Ensure adherence to quality management systems (QMS), regulatory standards (FDA, ISO), and industry best practices.
- Define the validation strategy, plan, and protocol for raw material test methods based on regulatory requirements and industry standards, as well as client requirements.
- Assess Supplier Change Notifications and changes to compendial monographs.
- Assist in handling of deviation investigations, lab investigations, OOS investigations, Non-conforming Material Investigations, Supplier Correction Action Requests, and Supplier Change Notifications.
- Support execution of change controls and CAPAs to facilitate testing, validation, system improvements and compliance.
- Maintains strict adherence to cGMP compliance and all applicable regulations.
- Support regulatory inspections, supplier audits, and client audits.
Requirements:
- B.S. in a scientific discipline with 8 years experience in pharmaceutical / biotech industry within Quality Control, or M.S. in a scientific discipline with a minimum of 6 years of experience.
- Significant experience with raw material testing programs and methodologies (FT-IR, Raman, NIR, Dot-blot, ELISA, and HPLC).
- Significant experience with interpreting and applying international compendial test monographs.
- Experience with raw material testing, inspection, and release for commercial products.
- Ability to communicate and work independently with scientific/technical personnel.
- Strong knowledge of GMPs, SOPs, and Quality system processes.
- Experience in cell and gene therapy manufacturing environment a plus.
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.
