Job Title : Senior Quality Control Gene Therapy Associate
Summary : My client is a leading Biopharmaceutical company working on a variety of gene therapies targeting rare diseases such as Duchenne Muscular Dystrophy. With over 40 products in their pipeline at this time in RNA Technologies, Gene Therapy and Gene Editing focused areas, it is an incredibly exciting time to join the organization. My client is looking for someone with a strong background in a cGMP environment and quality documentation, extensive experience with PCR methods, detail oriented and a strong team player. If this sounds like something that you would be a good fit for, do not hesitate to apply!
The Senior Quality Control Gene Therapy Associate will be responsible for :
- Performing laboratory analysis using qPCR and other methodologies.
- Testing and releasing clinical and commercial lots.
- Performing plasmid linearization and qualification as standards for use in PCR methods.
- Authoring test methods, development reports, SOP, Change Control and CAPA.
- Act as a liaison with CMO/CTL/CRO to coordinate method development and transfer across various sites as needed.
The Senior Quality Control Gene Therapy Associate should have the following requirements :
- Bachelor's Degree in a science related field.
- At least 3 years of experience in a cGMP environment
- Strong understanding of cell culture, qPCR and PCR enclosures.
- Experience in developing, validating, optimization and deploying molecular biology test methods.
If this sounds like something you would be interested in, please apply!