Senior QC Validation Specialist, Cell & Gene Therapy

ElevateBio

Waltham (MA)

On-site

USD 150,000 - 200,000

Full time

2 days ago

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Job summary

ElevateBio is seeking a Senior Specialist II in QC Validation to lead validation activities for cell and gene therapy programs at our Waltham manufacturing facility. You will design validation plans, execute experiments, and analyze data to ensure regulatory readiness and quality. Collaboration with Analytical Development, QC, and QA is essential to meet timelines.

Requirements include B.S. or M.S. in a related field with GMP QC lab experience and demonstrated expertise in gene/cell therapy

Qualifications

Bachelor's or Master’s degree with GMP QC lab experience and experience in cell/gene therapy testing.
Experience with validation planning and execution for commercial manufacturing.
Proficient in data analysis and regulatory compliance.

Responsibilities

Define validation strategy, plan, and protocol based on regulatory requirements and standards.
Collaborate with Analytical Development and QC testing to align data and timelines.
Analyze data and report validation results.
Ensure methods, equipment, and SOPs are suitable for validation in manufacturing.
Oversee change controls and support inspections/audits.
Hire, train, and mentor staff as needed.