Position:  Principal Scientist, Downstream Process Development
Location:  Cambridge, MA
Job Id:  029
# of Openings:  1

Summary:
This role will lead a team of (associate) scientists to conduct activities in late phase downstream purification process development, process scale up, internal and external technology transfer and manufacturing on floor support. Solid is looking for downstream process development candidates with experiences in purification process development, process characterization, Engineering scale up/down and technology transfer. Experience in managing direct reports is requested.
 
Key Duties & Accountabilities:
  • Development of scalable and robust downstream processes
  • Design experiments related to development, optimization, scale-up of all steps in a viral vector purification process and viral clearance study
  • Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding
  • Apply DOE and other advanced statistical techniques to design experiments related to process characterization
  • Author high-quality documents, including technical reports, SOPs, and experimental protocols
  • Serve as PD representative and participate in cross functional meetings
  • Contribute to scale up activities and draft tech transfer related documents (e.g. process description, process flow diagram)h
  • Conduct facility fit exercise
  • Review batch records and provide comments
  • Support MFG floor activities
  • Provide technical support (e.g. process/operational gap identification and troubleshooting) to MFG group
  • Support Solid’s Quality Assurance teams to help evaluate deviations, CAPA and Change Controls (both internal and external)
 
Education, Experience & Skills:
  • PhD in a scientific discipline with 8+ years related experience or master degree with 12 years or BS with 15 years
  • Solid theoretical understanding and hands-on experience in protein purification and analytical characterization
  • Hands-on experience with purification unit operations including filtration, different mode chromatography, UF/DF, AKTA, UNICORN, centrifugation
  • The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skills
  • Flexibility to switch between projects
 
Travel:
  • Up to 20% travel is required at times

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