Job Description

We are looking for a Downstream Scientist to join our client's Manufacturing Sciences and Technology (MSAT) organization based in 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 execute and qualify various downstream purification unit operations, ensure the proper and timely execution of purification processing at both pilot and/or bench scale of various biologics using a variety of unit operations, such, depth filtration, TFF (UF/DF), and chromatography.

• Experience with process development and characterization for a polysaccharide based programs and/or second-generation process development of biologics using various purification techniques.
• Independently plan, design, and execute downstream experiments to enable technology transfer of polysaccharide programs and/or second-generation purification processes to receiving units.
• Direct hands on experience with operation and maintenance of downstream equipment (AKTAs, Repligen TFF, etc.. and associated analytical tools (SoloVPE and Stunner etc..)
• Proficient with data analysis, technical writing, reporting, and presenting to internal teams.
• Support investigational studies and purification process troubleshooting as needed.
• Drive a culture of safety, continuous improvement and operational excellence initiatives within department.
• Independently plan, prepare, execute, and conclude critical material production campaigns.
• Emphasize strong communication, teamwork, growth mindset and cross functional collaboration with other project teams as needed

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 experience with data analysis tools such as Minitab, JMP, etc…
• Working knowledge of PAT applications development and implementation from bench scale to pilot
• Experience with HTS instrumentation for protein purification and process development
• Working knowledge of GxP/ICH/Quality compliance systems of the biopharmaceutical industry

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