Insight Global
POSITION SUMMARY/ POSITION RESPONSIBILITIES
We are looking for a Downstream Scientist to join the Manufacturing Sciences and Technology (MSAT) organization at a client site based out of Andover, MA. The MSAT downstream purification team supports purification process development and optimization for commercial processes and next generation process development.
This person will be expected to lead, develop and qualify purification techniques, ensure the proper and timely execution of purification processing at both pilot and/or bench scale of biologics using a variety of unit operations, such as precipitation, depth filtration, TFF, and chromatography.
Experience with process development and characterization for mAb based programs and/or second-generation process development of mAbs using various purification techniques.
Independently plan, design, and execute downstream experiments to enable technology transfer of mAb programs and/or second-generation purification processes to receiving units.
Hands on experience with operation and maintenance of downstream equipment (AKTAs, Repligen TFF, etc.. and associated analytical tools (SoloVPE, Stunner, Raman etc..)
Proficient with data analysis, technical writing, reporting, and presenting to internal teams.
Support manufacturing investigations and purification process troubleshooting.
Drive a culture of continuous improvement for 5S, TPM, and operational excellence initiatives within department.
Independently plan, prepare, execute, and conclude critical material production campaigns.
Emphasize communication, teamwork and cross functional collaboration with project teams
EDUCATION AND EXPERIENCE Bachelor’s degree or higher in a relevant discipline with at least 3 years of applicable bioprocess experience. Experience with process purification of biomolecules (mAbs, vaccines, etc…) from harvest to drug substance Familiarly working in GxP cross matrix organizations Lab-scale purification process development and troubleshooting experience with standard downstream equipment (e.g. AKTAs, Repligen TFF, etc…) Direct hands on experience and knowledge of templated processes such as mAbs, pDNA, mRNA etc… Proficient expereine with data analysis tools such as Minitab, JMP, KNIME etc… Working knowledge of PAT applications development and implementation from bench scale to pilot (FlowVPE, IVI Raman etc…) Experience with HTS instrumentation for protein purification and process development Working knowledge of GxP/ICH/Quality compliance systems of the biopharmaceutical industry
EDUCATION AND EXPERIENCE Bachelor’s degree or higher in a relevant discipline with at least 3 years of applicable bioprocess experience. Experience with process purification of biomolecules (mAbs, vaccines, etc…) from harvest to drug substance Familiarly working in GxP cross matrix organizations Lab-scale purification process development and troubleshooting experience with standard downstream equipment (e.g. AKTAs, Repligen TFF, etc…) Direct hands on experience and knowledge of templated processes such as mAbs, pDNA, mRNA etc… Proficient expereine with data analysis tools such as Minitab, JMP, KNIME etc… Working knowledge of PAT applications development and implementation from bench scale to pilot (FlowVPE, IVI Raman etc…) Experience with HTS instrumentation for protein purification and process development Working knowledge of GxP/ICH/Quality compliance systems of the biopharmaceutical industry