QC Scientist II — Cell & Gene Therapy

Germer International - Pharmaceutical Recruiting; Harmonville (PA); On-site; USD 85,000 - 120,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting seeks a QC Specialist II to support quality control testing for cell and gene therapy products in a GMP environment. Hands-on expert in cell-based immunology assays and flow cytometry is essential.

Role involves ensuring data integrity, coordinating with QC, QA, Manufacturing, and Analytical Development to maintain timelines and product quality for releases and stability programs.

Qualifications

• Bachelor's degree in Biology or related discipline.
• At least 5 years in cell/gene therapy or GMP biologics environments.
• Hands-on in cell-based immunology assays and flow cytometry.
• Knowledge of cGMP, data integrity, and analytical acceptance criteria.
• Experience with LIMS and electronic quality management systems.

Responsibilities

• Perform routine and non-routine QC testing to support manufacturing, product release, and stability programs.
• Execute cell-based immunology assays, including activation, cytokine, immune-function, and potency assays.
• Perform flow cytometry testing, including staining, acquisition, compensation, gating, and data interpretation.
• Test in-process samples, drug substance, drug product, raw materials, and stability samples against methods.
• Operate and troubleshoot laboratory instrumentation and data software.
• Review data, controls, calculations, and acceptance criteria for accuracy.
• Maintain GMP-compliant documentation and support investigations, deviations, OOS/OOT, CAPAs.
• Utilize LIMS and electronic quality systems to manage samples and quality records.
• Support analytical method transfers, troubleshooting, qualification, validation, and improvement.
• Partner with QC, QA, Manufacturing, and Analytical Development to meet timelines.

Skills

Cell-based immunology

Flow cytometry

GMP compliance

Data analysis

LIMS

Education

Bachelor's degree in Biology or related

Tools

LIMS

Data analysis software

Flow cytometer hardware

Job description

Germer International - Pharmaceutical Recruiting seeks a QC Specialist II to support quality control testing for cell and gene therapy products in a GMP environment. Hands-on expert in cell-based immunology assays and flow cytometry is essential.

Role involves ensuring data integrity, coordinating with QC, QA, Manufacturing, and Analytical Development to maintain timelines and product quality for releases and stability programs.