Quality Control Associate, Flow Cytometry - 119912

The Advanced Cell Therapy Laboratory (ACTL) offers expert assistance and hands-on services to investigators who require cGLP/cGMP systems and facilities. We aid in the transition from research and development to compliant and clinically-relevant manufacture of cell therapy products for IND-enabling studies or Phase I/II trials.

We provide assistance with cell banking, process scale-up, product characterization, document writing, product stability assessment, and packaging.

The Flow Cytometry QC Associate will oversee and provide technical support for the flow cytometer/cell sorter per ACTL client projects and manufacturing requirements. Incumbent will manage flow cytometry assays in the evaluation and analysis of immune cell responses. Additionally, incumbent will generate data, analyze results, and present results at meetings. This position will also be supporting QC in all other QC testing needs and all general aspects of running the QC lab as required.

Works on research data reporting assignments that are of moderate diversity in scope. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

• Bachelor's degree in related area (scientific discipline) and/or equivalent experience/training.

• Two (2+) or more years of relevant experience performing a flow cytometry analysis.

• Working knowledge of research function. Extensive experience and demonstrated ability to manage and operate flow cytometer(s) as well as train and advise personnel.

• Working skills in statistical analysis, systems programming, database design and data security measures.

• Working skills in analysis and consultation. Strong analytical and critical thinking skills, with the ability to quickly analyze problems.

• Skills to communicate complex information in a clear and concise manner both verbally and in writing.

• Strong skills using FlowLogic, MACSQuantify, FACS DIVA, or similar, as well as MS Word and Excel.

• Familiarity with the Miltenyi CliniMACs or similar flow cytometry devices, QPCR instruments, and absorbance readers.

• Experience using basic laboratory equipment; knowledge of safe laboratory procedures.

• Working knowledge of laboratory Good Manufacturing Practice (GMP), Food and Drug Administration (FDA), United States Pharmacopeial Convention (USP), and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Regulations.
• Hands-on experience in a pharmaceutical, biotech, drug manufacturing, or academic environment is required, with knowledge of clean room practices being essential.

• Employment is subject to a criminal background check.
• Willingness to work in Biosafety Level II environment where biological (including infectious agents and bloodborne pathogens) hazards are present.
• Must be available to work some weekends and evenings as needed.