Associate 2, MS&T

Essential Duties & Responsibilities

• Execute standard MSAT experiments and process-support studies using approved procedures.
• Support cell therapy process steps including cell culture, expansion, harvest, wash/concentration, formulation, cryopreservation, and thaw assessment.
• Collect and summarize process data including cell count, viability, growth kinetics, yield, recovery, and in-process control results.
• Support routine process monitoring and continued process verification activities.
• Aid in deviation investigations, CAPAs, change controls, and batch record reviews.
• Maintain accurate GMP and technical documentation.
• Support chain of identity, chain of custody, contamination control, aseptic processing, and data integrity requirements.

Qualifications

• Education/Training: - Associate degree in Biology, Biochemistry, Bioengineering, Chemical Engineering, Biotechnology, or a related field with 4–6 years of relevant experience, OR a bachelor’s degree in one of these fields with 2–4 years of relevant experience. A bachelor’s degree is preferred.
• Experience: - Experience in laboratory operations, cell culture, biologics manufacturing, process development, or technical operations.
• Knowledge: - Working knowledge of standard laboratory and cell-processing techniques.
• Skills: - Ability to perform routine calculations, data summaries, and documentation review.
• Certifications/Licenses: n/a