QC Molecular Scientist

  • Gaithersburg, Maryland
  • Full Time
Kelly Science and clinical has immediate needs for a QC Molecular Scientist with one of our clients located in Gaithersburg, MD . This is a great opportunity to get your foot in the door in a growing industry that is using cutting edge science to cure diseases! This is a 2 month contract role.

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

Overview:

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

Qualifications:
  • 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

Why Apply?
  • 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!!
    #P1

9884095

Job ID: 483090771
Originally Posted on: 6/27/2025

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