Downstream Scientist - Insight Global : Job Details

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