We are looking for a Downstream Scientist to support our pharmaceutical client in Andover, MA. This person will lead, develop, and qualify purification techniques for biologics at both pilot and bench scale. This role involves hands-on execution of purification processes using a variety of unit operations including precipitation, depth filtration, tangential flow filtration (TFF), and chromatography. The scientist will support technology transfer, process troubleshooting, and continuous improvement initiatives.
Key Responsibilities:
- Lead and execute purification processing using precipitation, depth filtration, TFF, and chromatography.
- Develop and characterize purification processes for monoclonal antibody (mAb) programs, including second-generation process development.
- Independently plan, design, and execute downstream experiments to support technology transfer of mAb programs.
- Operate and maintain downstream equipment such as AKTAs and Repligen TFF systems, and analytical tools including SoloVPE, Stunner, and Raman spectroscopy.
- Analyze data, prepare technical reports, and present findings to internal teams.
- Support manufacturing investigations and troubleshoot purification processes.
- Drive continuous improvement initiatives including 5S, TPM, and operational excellence.
- Plan and execute critical material production campaigns independently.
- Collaborate cross-functionally with project teams to ensure alignment and effective communication.
- Familiarity with mRNA Lipid nano particle formulation and Final Drug Product (FDP) processes
Qualifications
- 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