Analyst Ii – Qc Molecular Biology

Analyst II – QC Molecular Biology Overview

• The Analyst II – QC Molecular Biology will contribute to gene therapy quality control processes through molecular biology techniques and analytical methods.
• Perform ddPCR, qPCR, and other methods to support in-process testing, drug substance release, and stability assessments.
• Collaborate cross-functionally with teams in Quality Control, Analytical Development, and Quality Assurance.
• Participate in method validation, transfer activities, and critical reagent qualification for AAV-based gene therapy programs.
• Author technical documents, reports, and standard operating procedures to ensure compliance and quality standards.
• Support laboratory operations including instrument maintenance, housekeeping, and reagent qualification.
• Contribute to investigations, change controls, deviations, and CAPAs as required.
• Analyze data and prepare performance trend reports to maintain quality benchmarks.
• Engage in a dynamic, fast-paced environment requiring adaptability and multitasking skills.

Analyst II – QC Molecular Biology Key Responsibilities & Duties

• Conduct routine QC testing using ddPCR, qPCR, and related methods for gene therapy applications.
• Review and approve cGMP analytical data for release and stability testing.
• Maintain laboratory instruments and ensure compliance with qualification standards.
• Author and support quality events including change controls, deviations, and CAPAs.
• Prepare technical documents, SOPs, and validation protocols for internal and external methods.
• Support method transfer and validation activities for late-stage assays.
• Collaborate with internal and external stakeholders to ensure project success.
• Analyze data and prepare trend reports to monitor analytical method performance.
• Ensure compliance with safety protocols and laboratory standards.

Analyst II – QC Molecular Biology Job Requirements

• Bachelor's or Master's degree in Biochemistry, Biology, Chemistry, or related field.
• Minimum of 2 years of experience in a cGMP QC laboratory within the pharmaceutical or biopharmaceutical industry.
• Proficiency in ddPCR, qPCR, and related molecular biology techniques.
• Strong organizational, communication, and interpersonal skills.
• Ability to work independently and prioritize tasks effectively in a fast-paced environment.
• Physical ability to perform laboratory tasks including lifting up to 50 lbs and wearing protective equipment.
• Experience in authoring technical documents, SOPs, and validation protocols.
• Demonstrated ability to collaborate with cross-functional teams and stakeholders.
• Highly motivated with strong technical skills and adaptability to changing priorities.