- Location
- Watertown, MA
- Workplace
- Onsite
- Type
- Full-time
- Department
- Quality & Regulatory
- Education
- Master
- Source
- Lever
Description
The Quality Control - Analytics department supports a growing portfolio of cell and gene therapy (CGT) products, including CAR-T, iPSC, AAV, LVV and synthetic DNA products. We are immediately recruiting for a highly motivated QC Analyst I to perform laboratory testing with distinct technical but complementary focus within a fast-paced GMP environment. You will contribute to the development, qualification and execution of analytical methods supporting GMP release and characterization testing. Additionally, you will work cross-functionally with Analytical / Process Development, Manufacturing, and Quality Assurance to ensure methods meet regulatory and compendial expectations while supporting patient safety. This is an outstanding opportunity for a candidate to work under the guidance of a supervisor and mentor, manage time effectively, complete assigned analytical tasks in a cross-functional collaborative environment supporting development and cGMP manufacturing of cell and gene therapies.
This role focuses on the development and optimization of UHPLC-based biophysical analytical methods and/or PCR-based, and related molecular methods supporting CGT safety, identity, purity, strength and quality testing, including residual impurity and compendial applications such as Mycoplasma detection.