- Perform routine QC testing including, but not limited to: ddPCR/dPCR and qPCR test methods in support of in-process, release, and stability
- Support 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
- Author and revise SOPs/Forms and other relevant controlled documentation
- Perform peer review of both internal and externally generated data
- Support QC deviations, investigations, analytical method performance trending and root cause analysis, as needed
- Ensure 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
- Hands-on experience with performing dPCR, ddPCR and/or qPCR test method execution
- 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
- Experience with statistical analysis of analytical data and stability studies
- Experience with viral vectors is not required but experience with biologics
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Molecular Biology Quality Control Analyst I - Woburn, United States - Tandym Group
Description
A leader in the pharmaceutical industry is seeking a Quality Control Analyst I to join their team. In this role, the Molecular Biology Quality Control Analyst I will be responsible for supporting 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.
Responsibilities:
The Molecular Biology Quality Control Analyst I will:
Qualifications:
Desired Skills:
