ElevateBio · 4 hours ago
Specialist II, QC Raw Materials
Waltham, MA
Full-time
Onsite
Senior Level
$48.08/hr - $62.50/hr
6+ years expElevateBio is a technology-driven cell and gene therapy company, accelerating access to cutting-edge technologies and expertise to change the future of medicine. The QC Raw Materials Specialist II is responsible for executing and supporting the Quality Control Raw Materials program for Clinical and Commercial Cell and Gene Therapy programs, requiring technical depth and cross-functional collaboration.
BiotechnologyLife ScienceGeneticsTherapeutics
Responsibilities
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
Qualification
Required
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
Preferred
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
Company
ElevateBio
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come.
201-500 employees
H1B Sponsorship
ElevateBio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (19)
2023 (17)
2022 (6)
2021 (1)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$14M2021-03-23Angel· $14M
Leadership Team
Vikas Sinha
Chief Financial Officer
Michael Paglia
Chief Operating Officer, ElevateBio BaseCamp
Recent News
2024-05-10
Company data provided by crunchbase