QC Analyst II, Bioassay

QC Analyst II, Bioassay

Woburn, MA

Contract position through the end of 2025, then can renew

The QC Analyst will work with others in Quality Control and Analytical Development in a dynamic environment to support AAV-based gene therapy programs.  The QC Analyst will perform cell-based bioassays, ELISAs, and other biological methods in a GMP setting. In addition, the QC Analyst will support testing at external laboratories. Routine work includes release and stability testing, critical reagent qualification, method validation and transfer, critical reagent qualification, analyzing data, and authoring technical documents.

Responsibilities:

·        Performing immunoassays and cell-based assays in a GMP environment to support product release and stability.

·        Author SOPs and technical documents

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

·        Work independently to review and trend QC data

·        Support QC deviations, investigations, analytical method performance trending and root cause analysis.

·        Maintain the QC Bioassay laboratory (ex. Instrument qualification and maintenance. Passage cells, qualify critical reagents, etc)

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

Qualifications:

·        BS in Cell Biology, Molecular Biology, Biochemistry or a related discipline with 2+ years industry experience

·        Experience in routine mammalian cell culture strongly desired.

·        Experience performing immunoassays such as ELISAs required.  Experience with cell-based potency assays is desired.

·        Experience with statistical analysis preferred

·        Ability and desire to work in a fast-paced environment

·        Strong collaboration, team-working skills, and communication skills

·        Independently motivated and detail-oriented with good problem-solving ability

·        Strong communication, interpersonal and organizational skills