PCR/qPCR QC Lab Technician – Biopharma

Harba Solutions Inc.; Woburn (MA); Hybrid; USD 70,000 - 100,000; Full time

Job summary

Harba Solutions Inc. in the United States is seeking a QC Analyst to perform routine QC testing using ddPCR, dPCR, and qPCR methods to support in-process, release, and stability testing.

The role involves reviewing cGMP analytical data, supporting molecular biology operations, and participating in quality events, investigations, and method transfers for late-stage assays. Candidates should have a BS or MS in Biochemistry/Biology/Chemistry with at least two years of industry experience and

Qualifications

• Hands-on experience with performing dPCR, ddPCR and/or qPCR test methods.
• Experience in a cGMP QC lab is required.

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 internal and external analytical test methods
• Supports QC Molecular Biology laboratory operations (e.g. 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.

Skills

dPCR

ddPCR

qPCR

Education

BS or MS in Biochemistry/Biology/Chemistry or related with 2+ years experience

Job description

Harba Solutions Inc. in the United States is seeking a QC Analyst to perform routine QC testing using ddPCR, dPCR, and qPCR methods to support in-process, release, and stability testing.

The role involves reviewing cGMP analytical data, supporting molecular biology operations, and participating in quality events, investigations, and method transfers for late-stage assays. Candidates should have a BS or MS in Biochemistry/Biology/Chemistry with at least two years of industry experience and