Newark Metro Area, New Jersey
BS/MS Biochemistry, Biology or related discipline with equivalent experience. Will consider entry level, but should have the relevant academic experience.
Ideal experience is QC and flow cytometry
Good laboratory documentation skills.
Understands cGMP documentation requirements.
Experience with flow cytometry, automated cell counting, ELISA, PCR, etc.
Able to work well in team environment to achieve results.
Responsible for assisting with laboratory analysis for commercial release and routine stability testing.
May conduct routine release and stability analyses of developmental and commercial compounds, prototype formulations and finished products in support of clinical testing for IND and NDA submissions.
Perform laboratory analysis under guidance of a supervisor or designee.
Conduct testing independently and may assist other analysts in analytical testing including flow cytometry, automated cell counting, ELISA, PCR, and other analytical laboratory testing.
Conducts routine analytical experiments using analytical methods and procedures.
Draws basic conclusions from data and results and communicates with other analysts and management.
Performs instrument/method troubleshooting within analytical method parameters and management guidance.
Performs testing for development and commercial samples, release and stability samples in accordance with established methods, specifications and protocols with limited supervision.
Documents/reviews laboratory work using laboratory notebooks/worksheets that is detailed, timely and in compliance with GLP/cGMP requirements.