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Quality Control Scientist Flow CytometrySouth Carolina
Job Description:

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

company goals.

Job Requirements:

- 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,

granulocytes)

- 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

(presentation)

- 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

 

Requirements:

- MS or higher degree with 5+ years of cGMP experience in a quality control

biotechnology/pharmaceutical environment. Immunology or related degree preferred.

- Experience working with cell and/or gene therapy products for clinical trials

- Ability to process large amounts of paperwork in a timely and efficient manner

- Ability to work in a team‐oriented, multidisciplinary and multicultural environment

- Willingness to train and involve less experienced staff on new techniques as part of technology

transfer or assay development

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