Specialist II, QC Raw Materials
About The Position
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.
Nice To Haves
- 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
