Job Title: Assay Transfer & Qualification Scientist I
Location: Gaithersburg, MD (On-site)
Contract Duration: 2 months
Pay Rate: $43$45/hour (W2)
Start Date: ASAP
Work Schedule: MondayFriday, 8:00 AM 5:00 PM
A leading biotechnology company is seeking a Scientist I to support assay development, transfer, and qualification activities for GMP and non-GMP applications. This is a great opportunity for someone with a strong molecular biology background who thrives in a fast-paced, regulated lab environment.
Key Responsibilities:Perform and support QC test methods including nucleic acid extraction, qPCR, sequencing, ELISA, agarose gels, and restriction digests
Develop, optimize, and qualify analytical methods for GMP lot release
Write experimental protocols, execute and document qualification studies, and revise SOPs
Maintain detailed, GMP-compliant records of assay development activities
Analyze data using statistical tools (e.g., JMP) and prepare technical reports
Evaluate and implement new technologies for biological and molecular assays
Act as subject matter expert (SME) and assist in training analysts
Support OOS investigations, CAPAs, deviations, and assist with raw material qualification
Manage lab inventory, order supplies, and perform SAP entries
Bachelors degree in life sciences or related field required; Masters preferred
25 years of relevant industry experience in QC, assay development, or validation
Hands-on experience with molecular biology techniques (e.g., qPCR, ELISA, sequencing)
Strong understanding of GMP, assay lifecycle, and regulatory standards (ICH, FDA, USP, EP)
Familiarity with design of experiments (DOE) and statistical software (e.g., JMP)
Excellent documentation, communication, and teamwork skills
Ability to work independently with minimal supervision
Competitive hourly pay
Immediate start with a well-established biotech company
Opportunity to expand skills in a regulated, high-impact environment
APPLY NOW FOR IMMEDIATE CONSIDERATION!!
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