Molecular Biology Lab Technician

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

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.