Responsibilities Overview:

Support and lead design and develop analytical methods for the characterization and release of viral vectors and CAR-T cells
Assist to Identify and implement opportunities for analytical method improvement and participate optimization of existing analytical methods to enhance sensitivity and efficiency.
Perform method qualification studies in accordance with regulatory guidelines.
Conduct routine quality control assays
Perform general lab and equipment maintenance duties.
Participate in technical troubleshooting and problem investigation.
Prepare, evaluate, and present data internally to cross functional teams.
Prepare detailed and accurate documentation of experimental procedures, results, and conclusions.
Stay current with advances in analytical techniques and industry trends.

Required Qualifications

Bachelor’s or master’s degree in biology or closely related discipline, and with 3-5 + years of experience. Direct experience in the biotechnology industry is required.
Proficient in aseptic technique for cell culture and cell-based assays.
Strong experience in analytic techniques, including flow cytometry, qPCR/dPCR, and ELISA etc.
Flexible to support various analytical activities and to learn new techniques outside of existing field of expertise.
Ability to work independently and collaboratively in a fast-paced environment.
Highly organized and strong written and verbal communication skills.
Strong laboratory documentation practice with high scientific integrity.
Familiarity with regulatory requirements and guidelines (FDA, ICH, etc.) for biopharmaceutical manufacturing.