Quality Control Scientist
Will serve as a subject matter expert and leader of the quality team focused on assay technology transfer, development and release testing to meet client requirements and deadlines.
Requires a strong background and understanding of immunology (especially with respect to
current cell‐based therapies) and technical expertise in assay‐based cell characterization methods for
analyzing cell function/potency, identity, safety, purity etc. Ability to work effectively
and autonomously as part of a multi‐disciplinary team as well as a strong motivation to achieve
- Significant multi‐color flow cytometry (5+ years) experience analyzing lymphoid/myeloid cells is
required (PBMC, T cells and subsets, B cells, NK cells, dendritic cells, monocytes, macrophages,
- Significant cell culture experience and understanding
- Project leader for assigned client initiatives with potential oversight of staff
- Strong background and experience with cell‐based immunological in vitro methods (e.g. MLR,
cytotoxicity, HLA‐restriction, CTLp, T cell proliferation, etc.)
- Knowledge and technical expertise in areas of assay development, optimization and validation
leveraging off‐the‐shelf technologies in combination with novel ideas as required (cell‐based
assays, ELISA, flow cytometry, PCR/other molecular biology‐based assays)
- Basic understanding of emerging T cell / CAR T biotechnology
- Study design, data/statistical analysis, reporting results in both written and oral format
- An understanding of cGMP/GLP regulations as well as excellent documentation skills in order to
complete paperwork dealing in all aspects of Quality Control
- Familiarity with basic core QC areas including product/material stability, trending, comparability,
qualification/validation, compendial methods, etc.
- Excellent writing skills. Experience in drafting of Standard Operating Procedures (SOPs),
protocols, reports, etc.
- Understanding/familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations
associated with the quality control of biologic/cell therapies.
- Ability to problem solve and troubleshoot as necessary