Responsibilities:

• Design and execute in vitro experiments to assess and develop novel assays/biomarkers, techniques and technologies to characterize cell therapy development processes. Identify and determine appropriate ranges of (critical) assay process parameters to ensure robust, repeatable and accurate results with minimal supervision.
• Champion assessing, designing, developing, evaluating and implementing technologies, processes and methods to improve understanding of therapeutic cell product candidates, intermediates, media, reagents, growth factors and other material critical to safety and quality of drug substance and drug product for use in patients.
• Ensure that experiments, analytical methods, and data meet the requirements for the intended use of assays, which includes characterization, lot release and comparability.
• Perform flow cytometry, ELISA, analytical, cell-based, PCR-based and other assays as required.
• Collect and analyze data from various assays, track and trend data, and establish specifications for critical process controls.
• Author, review and approve SOPs, study protocols, reports and other scientific and quality documents.
• Ensure that assays meet regulatory requirements in all regions relevant to the company, in compliance with the Quality Management System.
• Identify and evaluate new technologies and incorporate them into product quality assessments as appropriate.
• Perform technology transfer of assays to the Quality Unit through training of personnel and support of further qualification/validation efforts.
• This position requires hands-on laboratory work.
• Present scientific data to colleagues in group meetings, prepare and present internal and external presentations (presentations, posters, publications).
• Perform additional duties to support the safe and efficient operation of the laboratory, and other duties as assigned.

Requirements:

• Bachelors in biological sciences with 2 years' experience, or Masters with 0-2 years' experience, preferably in a biotechnology or pharmaceutical industry setting
• Highly familiar with standard analytics equipment and procedures including, but not limited to Flow cytometry, ELISA, DNA/RNA analysis, cell-based and screening assays, protein analysis, sterility, mycoplasma, endotoxin, cell-counting, qPCR, ddPCR, IHC/pathology
• A solid understanding of aseptic techniques and technologies
• Demonstrated ability to develop and optimize biological and/or chemical assays
• Demonstrated ability to be highly productive and successful in a fast paced work environment with excellent attention to details and meticulous bench work
• Demonstrated ability to cooperate with a larger team to solve a wide range of problems in creative and practical ways
• Demonstrated ability to write technical documents with minimal supervision
• Competency in computer skills and familiarity with Microsoft Office programs (Word, Excel, PowerPoint)