- Performs routine QC testing including, but not limited to: ddPCR/dPCR and qPCR test methods in support of in-process, release, and stability.
- Supports routine laboratory operations (equipment cleaning, laboratory cleaning, inventory control, logbook management)
- Support development, technical transfer and validation of qPCR and ddPCR-based assays and other methods for lot release and stability as needed.
- Authors and Revises SOPs/Forms and other relevant controlled documentation.
- Performs peer review of both internal and externally generated data.
- Support QC deviations, investigations, analytical method performance trending and root cause analysis, as needed.
- Ensures laboratory inspection readiness and assists with troubleshooting/continuous improvement as needed.
- BS or MS in Molecular Biology, Cell Biology, Biochemistry or a related discipline with 1+ years industry experience. QC GMP experience is required.
- Hands-on experience with performing dPCR, ddPCR and/or qPCR test method execution required.
- Experience with statistical analysis of analytical data and stability studies preferred
- Experience with viral vectors is not required but experience with biologics preferred
- Ability and desire to work in a fast-paced, start-up environment
- Strong collaboration, team-working skills and communication skills
- Independently motivated and detail-oriented with good problem- solving ability
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Analyst I, Quality Control Molecular Biology - Woburn, United States - The Steely Group
Description
Reporting to the Director, QC Molecular Biology, the Analyst I - QC Molecular Biology will support the gene therapy program pipeline including but not limited to routine GMP testing of AAV vector analytical methods such as GC titer determination by ddPCR and qPCR, impurity testing, and other methods as needed. Adaptable to perform in a fast-paced environment while still delivering high-quality results, this Analyst I - QC Molecular Biology will be required to have strong interpersonal skills and be able to work under minimal supervision.
Responsibilities:
