Independently 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
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
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
Conduct 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 7+years’ experience, or Masters with 6+ years’ experience, preferably in a biotechnology or pharmaceutical industry setting
Strong experience with human pluripotent stem cell or mammalian cell culture
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 and ddPCR
Design and develop assays for PCR analytics
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)
Benefits
Additional STI & LTI bonuses
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
in vitro experimentsassay developmentflow cytometryELISAPCRcell culturedata analysisSOP authoringbiological assaysanalytical methods
Soft skills
attention to detailteam collaborationproblem-solvingtechnical writingtime managementcommunicationindependenceadaptabilitymeticulousnessproductivity