A global biotech company that is passionate about developing genetic medicine to help rewrite the stories of those with rare diseases is looking for a Lead Quality Control Associate and a Sr. Quality Control Associate in Gene Therapy. This company has over 40+ programs with multiple commercialized and clinical products in its pipeline. Due to the strides the company is making in the life science industry with genetic medicine, the organization is looking to aggressively grow their team. This is the right opportunity to take on a more senior position in the QC department!
Key Job Responsibilities:
- Head the internal analytical development, qualification/validation activities, testings, and CMO support of Gene Therapy test methods such as ddPCR and qPCR.
- Perform Nanodrop UV/Vis and Agarose Gel testing.
- Function as company liaison with CMOs to coordinate method development and transfer.
- Maintain lab records and documentation.
- Assists the training of junior associates in Gene Therapy test methods.
- Assists in authoring and evaluating quality documents including SOPs, development reports, OOS/OOT, study protocols, validation reports, CAPA, and Change Controls.
- Assess CRO/CMO documentation and results.
- Lead the design, screening, and document of PCR primer/probes to be used in quantification of viral vectors.
Qualifications:
- B.S. degree preferably in molecular biology, cell biology or virology; M.S. is preferred.
- Minimum of 5 years of experience in QC and/or relevant experience.
- Knowledge and experience with qPCR or ddPCR methods is required.
- Experience with cell or gene therapy products preferred.
- Experience in general laboratory experimentation, documentation is required
- Working knowledge in developing, validating, and deploying molecular biology test methods is a plus.
