Within the Biodevelopment Process Development group, will execute projects including developing purification processes and analytical methods for a variety of therapeutic candidate proteins including monoclonal antibodies and Fc fusion proteins. The scope of work includes protein purification, biochemical and biophysical characterization, as well as to develop, validate and transfer robust analytical methods required for successful drug development and manufacturing. Compile and analyze experimental data to generate process knowledge and decide on next experimental steps. Write development and validation reports and ensure their timely delivery. Prepare and present project updates to global project team and to upper management. Execute client projects according to budget and timelines given to the project team.
Design fit-for-purpose purification experients and analytcal methods according to the stage of development
Perform analytical analyses including SDS, HPLC, cIEF, SPR, LAL, qPCR, immunoassay and other biophysical/biochemical methods.
Responsible for activities ranging from protein purification, filtration, biochemical and biophysical characterization of proteins.
Execute routine protein purification with affinity, size exclusion, ion exchange, and hydrophobic interaction chromatography using AKTA systems (Unicorn software).
Consolidated background in protein chemistry and protein analysis by chromatographic, electrophoretic and spectroscopic techniques.
Develop, validate and transfer robust process development and analytical methods required for successful drug development and manufacturing.
Develop novel multistep purification processes to ensure viral clearance, endotoxin, host cell protein and DNA removal and apply standard methods to purify proteins from the mg to gram scale.
Perform, develop and optimize robust, efficient, scalable strategies to improve process performance. Activities will include small-scale and pilot scale purification studies.
Apply DOE methods to purification activities.
Who You Are:
B.S / M.S. in biotechnology with 2 5 years in the biopharmaceutical industry
Solid theoretical basis and hands-on experience in protein purification and analytical characterization.
Hands-on experience with purification unit operations including filtration, chromatography, TFF, UF/DF, AKTA, UNICORN and HPLC systems. Strong hands-on experience in troubleshooting and routine instrument maintenance.
Knowledge and skills in biochemical characterization of proteins including analytical and biophysical techniques. Experience with protein formulation strategies is desirable.
Experienced in protein purification via affinity, hydrophobic interaction (HIC), ion exchange (IEX), size exclusion (SEC) and mixed-mode chromatography
Excellent presentation and communication skills
Results-oriented with ability to work and deliver under pressure
Job Requisition ID: 179328
Career Level: C - Professional (1-3 years)
Working time model: full-time
Nearest Major Market: Boston
Job Segment: Chemistry, Analytics, Biochemistry, Biotech, Scientist, Science, Management