Job Title : Lead Engineer, QA Validation
Summary : My client is a leading Biopharmaceutical/Biotechnology company focused on targeting rare diseases by engineering genetic therapies. As a mid-size company with about 1000 employees between the Cambridge and Andover MA locations. With over 40 products in their pipeline between RNA technologies, gene therapy and gene editing, my client is looking to build out their quality team to ensure the most effective and efficient process. They are looking for highly organized, self-motivated individuals to join their team at this time.
The Lead Engineer, QA Validation will be responsible for :
- Calibration and maintenance of all lab equipment, instrumentation and supporting utilities.
- Develop and support the validation of processes associated to drug substance manufacturing process and support technical transfer of manufacturing processes at designated CMO sites.
- Independently coordinate and directly interface with multiple departments both internally and with CMO and lab equipment vendors.
The Lead Engineer, QA Validation should have the following requirements :
- Bachelor's Degree in a science related field.
- At least 8-12 years of relevant experience in a pharmaceutical/biopharmaceutical/biotech industry.
- Experience with both laboratory and manufacturing validation.
- Experience in CMO and with drug substance manufacturing,
- About 2-4 years of experience in Quality Assurance is preferred.
- Experience in Gene Therapy is desired.
If this sounds like something you would be interested in, please apply!