Molecular Biology Lab Technician

Job Responsibilities:

Performs routine QC testing including but not limited to: ddPCR, dPCR, and qPCR test methods in support of in-process, release, and stability.

Review and approval of cGMP analytical data for release and stability testing from interna and external analytical test methods  

Supports QC Molecular Biology laboratory operations (ex. Instrument qualification and maintenance. Housekeeping, qualify critical reagents, etc).

 Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed. 

Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/ validation protocol, Method transfer/ validation report for internal and external methods.   

Support method transfer and validation activities for development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programs.

Author analytical method performance trend reports, as needed.

Work with cross functional teams with both internal and external stakeholders.

Requirements:

Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is a must.

BS or MS in Biochemistry, Biology, Chemistry or a related discipline with 2+ years (BS/MS) relevant industry experience

Hands-on experience with performing dPCR, ddPCR and/or qPCR test method execution required.