Specialist II, QC Raw Materials

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 Raw Materials Specialist II is an experienced individual contributor responsible for executing and supporting the Quality Control Raw Materials program for Clinical and Commercial Cell and Gene Therapy programs. This role requires technical depth, independence, and ownership of moderately complex raw material program activities. The Specialist II partners cross‑functionally with Supply Chain, Quality Assurance, Manufacturing, MS&T, and external contract labs to ensure raw materials are qualified, tested, and released in compliance with cGMP and regulatory requirements.

Here’s What You’ll Do:

• Serve as a primary contributor for onboarding of new raw materials and components, supporting the raw material qualification lifecycle program, including authoring and maintaining material specifications, risk assessments, and supporting vendor evaluations.

• Support and contribute to deviation investigations, laboratory investigations, OOS investigations, non‑conforming material investigations, supplier corrective action requests, and supplier change notifications to maintain site compliance.

• Interface effectively with cross-functional stakeholders including Clients, Manufacturing, Supply Chain, MS&T, Process Development, and Analytical Development to support material readiness and manufacturing needs.

• Support execution of change controls and CAPAs related to raw material testing, qualification, and continuous improvement initiatives.

• Apply working knowledge of compendial monographs to support raw material testing strategies and assessments.

• Support team in executing and documenting raw material receipt, testing, and disposition activities within applicable LIMS and ERP systems; ensure accurate and timely data entry, review, and reconciliation to support material release, inventory control, and manufacturing readiness.

• Actively support regulatory inspections, client audits, and internal audits by providing documentation, data, and subject‑matter input.

• Serve as a technical representative for the Raw Materials workstream on client-facing programs, providing subject-matter input, supporting client communications, and representing QC Raw Materials execution and readiness.

• Monitor project status and key raw material milestones across cross-functional forums, including participation in Program Management Organization (PMO) meetings, to ensure alignment with program timelines and manufacturing readiness.

• Interface with external contract testing laboratories and serve as a point of contact for routine and project-based raw material testing coordination, including scheduling, sample shipment, data review, issue resolution, and support of Purchase Order processing and invoice reconciliation.

Requirements:

• Bachelor’s degree in a scientific discipline with 6+ years of experience in a GMP pharmaceutical or biotechnology environment within Quality Control or a related raw materials technical area; or an advanced degree with equivalent relevant experience.

• Hands‑on experience with raw material testing programs and methodologies related to Cell and Gene Therapies or Biotechnology products.

• Working knowledge of interpreting and applying compendial test monographs (USP, Ph. Eur).

• Demonstrated understanding of GMPs, SOPs, and quality system processes.

• Strong organizational skills and the ability to communicate effectively with scientific and technical personnel.

• Experience interfacing with contract testing laboratories preferred

• Experience in a cell and gene therapy manufacturing environment preferred.

• Preferred experience in Commercial program.

• Experience with Clinical to Commercial transition for Raw Material Program highly desirable.

• Experience participating in laboratory investigations, including OOS investigations.

The budgeted range for this position is $48.08-$62.50. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.

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.