Molecular QC Analyst II: PCR & cGMP Methods

Tandym-Group; Woburn (MA); On-site; USD 55,000 - 78,000; Full time

Job summary

Tandym-Group is seeking a Quality Control Analyst II to join its Molecular Biology team in Woburn, MA. The role focuses on routine QC testing including ddPCR, dPCR, and qPCR to support in-process, release, and stability.

You will review cGMP analytical data, assist instrument qualification, and contribute to method transfer and validation activities for late-stage AAV-based programs, collaborating with internal and external stakeholders.

Qualifications

• 2+ years of related industry experience.
• Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry.
• Hands-on experience with performing dPCR, ddPCR and/or qPCR test method execution.
• Strong collaboration and team-working skills.
• Strong communication, interpersonal and organizational skills.

Responsibilities

• Perform routine QC testing including ddPCR, dPCR, and qPCR in-process, release, and stability.
• Review and approve cGMP analytical data for release and stability testing.
• Support QC Molecular Biology lab operations (instrument qualification, maintenance, reagents qualification).
• Author and support quality events; Change controls, Deviation, CAPA, OOS Investigations.

Skills

cGMP QC lab experience

Biochemistry knowledge

Team collaboration

Communication skills

Education

Bachelor's degree in Biochemistry/ Biology/ Chemistry

Master's degree in Biochemistry/ Biology/ Chemistry

Job description

Tandym-Group is seeking a Quality Control Analyst II to join its Molecular Biology team in Woburn, MA. The role focuses on routine QC testing including ddPCR, dPCR, and qPCR to support in-process, release, and stability.

You will review cGMP analytical data, assist instrument qualification, and contribute to method transfer and validation activities for late-stage AAV-based programs, collaborating with internal and external stakeholders.