Quality & Validation Scientist (Assay Transfer)

Assay Transfer, Quality & Validation Scientist (Temporary / Temp-to-Hire)

Location: Gaithersburg, MD (On-site)

Duration: 6 months (possible conversion to direct hire depending on headcount)

Working Hours: Monday–Friday, 8:00 AM – 5:00 PM

Hourly Pay Rate: $40–$45/hr

Role Overview

We are seeking a driven Assay Transfer, Quality & Validation Scientist to join our QC team. These roles will support biological and molecular assay development, optimization/robustness, method transfers, qualification/validation, and training of staff. You will operate with minimal supervision, maintaining assay integrity in a GMP environment and being a subject matter expert for transferred/qualified assays.

Key Responsibilities

• Develop, optimize, transfer, and validate analytical methods (both GMP & Non-GMP), including creating Experimental Protocol Summaries (EPS), executing qualification/validation, and writing and revising SOPs.
• Design robust qualitative and quantitative assays; determine controls, optimize assays, assess robustness. Carry out stability studies of critical reagents and standards qualification.
• Maintain fully compliant records of all assay development, transfer, qualification, validation activities per cGMP.
• Evaluate and implement new technologies for biological / molecular assays.
• Act as SME: train analysts on new or transferred assays.
• Establish and maintain assay trending metrics in alignment with regulatory standards (USP, EP, FDA, ICH).
• Perform/support QC test methods: nucleic acid extraction, qPCR, restriction digests, agarose gels, sequencing, ELISA, flow cytometry, cell culture.
• Manage QC materials / lab supplies inventory; monitor, order, record via SAP.
• Assist in troubleshooting assay issues, supporting investigations (OOS, CAPAs, deviations etc.).
• Present new reagents/materials to Raw Material Board; manage part numbering and SAP integration.

Minimum Qualifications

• Bachelor’s degree in life sciences (e.g. biology, molecular biology, biochemistry); Master’s preferred.
• Minimum of 5 years’ relevant experience in assay development / validation / transfer; or equivalent combination of education + experience.
• Strong proficiency in Biological / Molecular assay techniques and methodologies.
• Understanding of the full analytical method lifecycle: development, qualification, validation, transfer, maintenance.
• Working knowledge of GMP compliance and Quality Control in a regulated environment.
• Statistical skills; experience with design of experiments (DOE) and statistical analysis tools (e.g. JMP) preferred.
• Strong attention to detail, excellent organizational, written & oral communication skills.
• Familiarity with ICH, EP, USP, FDA regulatory standards as they apply to assays and cell therapy/bio-assay products.

Why this role may appeal

• Hands-on exposure to high-impact molecular and biological assay work in a regulated environment.
• Opportunity to become a subject matter expert and train others.
• Potential to convert to direct hire, depending on future departmental needs.

APPLY NOW FOR IMMEDIATE CONSIDERATION!!

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