QC Analyst II, Molecular Biology - Gene Therapy ddPCR

The Steely Group

Woburn (MA)

On-site

USD 75,000 - 105,000

Full time

14 days+

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Job summary

The Steely Group is seeking a QC Analyst II for its Gene Therapy Quality Control Molecular Biology group. The role involves performing analytical methods such as ddPCR, dPCR, and qPCR to support in-process, release, and stability testing for AAV-based programs.

You will collaborate with Quality Control, Analytical Development, and QA teams to ensure compliance and timely data delivery. Responsibilities include data review of cGMP analyses, instrument qualification support, SOP and method

Qualifications

Experience in a cGMP QC lab is required.
BS or MS in Biochemistry, Biology, Chemistry or related discipline with 2+ years of experience.
Hands-on ddPCR, dPCR and/or qPCR method execution.

Responsibilities

Performs routine QC testing including ddPCR, dPCR, and qPCR for in-process, release, and stability.
Review and approve cGMP analytical data for release and stability testing from internal and external methods.
Supports QC Molecular Biology lab operations (instrument qualification, maintenance, housekeeping, reagents qualification).
Author and support quality events; change controls, deviations, CAPA, OOS investigations as needed.
Write, prepare, and present technical data, reports, SOPs, and transfer/validation documents.
Support method transfer and validation activities for late-stage assays in AAV-based gene therapy programs.
Author analytical method performance trend reports as needed.