What are the responsibilities and job description for the QC Associate I, Raw Materials (Contract) position at ElevateBio?
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 QC Associate I will support the QC Raw Material Program. You will be primarily responsible to receive, sample, inspect, test, and release materials for use in GMP manufacture.
Here’s What You’ll Do
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.
The Role
The QC Associate I will support the QC Raw Material Program. You will be primarily responsible to receive, sample, inspect, test, and release materials for use in GMP manufacture.
Here’s What You’ll Do
- Receive, sample, inspect, test, and release incoming raw materials, reagents, and components in compliance with SOPs. This includes maintaining compliant documentation. This may include management of outsourced analytical, microbial, and biochemical testing.
- Maintain laboratories in a safe, cGMP compliant and inspection-ready state. This includes maintenance of the labs in a clean and orderly manner, ensuring logbooks and associated documents are reviewed on time, ensuring all equipment are within calibration and all chemicals/reagents are within expiry. Maintain inventory of supply and reagents.
- Perform routine maintenance of lab equipment.
- Support onboarding and qualification of materials by assisting in the preparation of documentation to facilitate material release and testing as part of technology transfer.
- Maintain strict adherence to cGMP compliance and all applicable regulations.
- BS in a technical discipline with at least 0-2 years’ experience in GMP pharmaceutical / biotech industry within Quality Control, MSAT, Process Development or related area to Raw Materials technical expertise.
- Ability to work independently.
- Ability to communicate/collaborate with scientific/technical personnel.
- Excellent organizational skills and attention to detail.
- Experience with raw material testing programs and quality control methodologies (FT-IR, Raman, NIR, Dot-blot, ELISA, HPLC, pH, Visual Inspection, etc.) is a plus.
- Knowledge of GMPs, SOPs, and Quality System processes is a plus.
- Experience with electronic management systems (SAP, Veeva, LIMS) is a plus.
- Experience in cell and gene therapy manufacturing environment is a plus.
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.
