Scientist, QC Analytical

$38.46 - $48.07 per hour

Catalent

Catalent seeks a QC Analytical Scientist to perform analytical testing and assays for GMP manufacturing of gene therapy and viral vector products. The role involves hands-on laboratory work, documentation, method development support, and regulatory compliance at the FDA-licensed Harmans, Maryland facility.

Responsibilities

Perform analytical assays including ELISA, qPCR, ddPCR, HPLC, gel electrophoresis, and pH/osmolality testing
Document testing activities and generate protocols, reports, and SOPs in compliance with GMP/GDP standards
Support QC method verification and release/stability testing for raw materials and finished products
Write laboratory investigations, deviation reports, and CAPAs; conduct statistical analysis and trending
Maintain instrumentation, troubleshoot technical issues, and review records for accuracy and compliance

Requirements

Bachelor's degree in Life Sciences with 2+ years cGMP QC lab experience, or Master's with 1+ year cGMP experience
Hands-on QC experience in biologic, pharmaceutical, or medical device industry with strong GMP knowledge
Experience writing standard operating procedures and applying regulatory principles
Strong biochemistry foundation and attention to detail in fast-paced environments
Proficiency in Microsoft Excel and Word for data management and documentation
Experience with ELISA, qPCR, ddPCR, HPLC, or Capillary Electrophoresis techniques preferred

Compensation: $38.46–$48.07 per hour plus bonus

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Vacancy posted 2 days ago

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