Bioanalytical Development Scientist
Newark Metro Area, New Jersey
Responsible for carrying out laboratory experiments and analysis in support of characterization/qualification, validation and/or transfer of analytical methods.
Conduct experiments/analysis independently and may assist other scientists/analysts with experiments employing various methodologies, including: cell culture, flow cytometry, ELISA, cell counting, qPCR, etc.
Draw basic conclusions from data and results and communicate effectively within/across groups.
Contribute to scientific technical writing of qualification, validation and/or transfer plans and reports.
Perform instrument/method troubleshooting and investigations within analytical method parameters and management guidance.
Use laboratory notebooks to document laboratory experiments in compliance with cGMP requirements.
Maintain a clean and safe work environment in accordance with policies/procedures and OSHA safe practices.
Provide training for analytical release and stability assays.
BS/MS in Biology, Cell Biology, Biochemistry or relevant discipline with equivalent experience.
Ideally a minimum of 2 - 4 years recent laboratory experience.
Experience/knowledge with flow cytometry, ELISAs, microbiology, cell culture, qPCR.
Basic understanding of analysis software, experience in statistical design and analysis of experiment is a plus.
Understanding of basic experimental design and scientific reasoning.
Experience in assay transfer, instrument performance qualification, training or technical writing is a plus.
Highly motivated, willingness to acquire new skills and ability to work with minimal supervision.
Must be proficient in MS Office suite of software.
Good communication skills.
Able to work well in team environment to achieve results.