BlueRock Therapeutics is looking to solve neurological and ophthalmic diseases by developing novel cell therapies. The company needs to establish critical characterization and quality assays for their cell therapy products and manufacturing processes.
Requirements
- 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 write technical documents with minimal supervision
- Competency in computer skills and familiarity with Microsoft Office programs (Word, Excel, PowerPoint)
Responsibilities
- Independently design and execute in vitro experiments to assess and develop novel assays/biomarkers, techniques and technologies to characterize cell therapy development processes.
- 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.
Other
- Bachelors in biological sciences with 7+years’ experience, or Masters with 6+ years’ experience, preferably in a biotechnology or pharmaceutical industry setting
- Demonstrated ability to cooperate with a larger team to solve a wide range of problems in creative and practical ways
- 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.
