Duties: Title: Process Scientist - Protein Purification Downstream Scientist.
This position focuses on supporting preparative purification process development for the manufacture of Monoclonal Antibodies (mABs). Frequently executes experiments independently at bench scale under GLP/GMP environment, generating and interpreting data to. Works independently and in teams on a daily basis using chromatography and filtration techniques (e.g. IEX, Affinity, TFF, Viral Filtration, etc.). Summarizes data and/or authors technical reports for experiments and presents results to team. AKTA, Unicorn experience is viewed as a critical skill.
Candidate is expected to be able to independently operate an AKTA system.
Develop and optimize scalable purification processes
Perform comprehensive data analysis or process statistics, identify process deviations, prepare technical reports.
Exchange technical information with team members for troubleshooting and process improvement. Propose and execute changes to improve process performance, robustness.
Participate in department level training and development opportunities. Provide training and guidance to more junior scientists, if possible.
Ensure compliance with cGMP guidelines, quality policies, directives, and procedure. May drive SOP/BPR generation, review & approval process.
Any other duties as assigned
Education: Preferred: Bachelor's Degree and 2-3+ years of relevant experience, or Master's degree and 1+ year of relevant experience
Desired majors include: chemical or biochemical engineering, biopharmaceutical, biotechnology, bioprocessing, biochemistry. Previous experience with purification of downstream mAbs is highly encouraged
Keywords: AKTA, Unicorn, Avant, Ready, Pure, FPLC, chromatography, preparative, downstream processing, purification, filtration, pilot scale, bench scale, monoclonal antibodies, Mab, statistics, JMP, data analysis, GLP