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Solid Biosciences

Senior Scientist, Downstream Process Development

306 - Process Development – Cambridge, Massachusetts
Department 306 - Process Development
Employment Type Full-Time
Minimum Experience Experienced

Summary:

This role will support late phase downstream purification process development activities, process scale up, internal and external technology transfer, and manufacturing on floor activities. Solid is looking for downstream process development candidates with experiences in purification process development, process characterization, engineering scale up/down and technology transfer. Some experience in managing more junior members is preferred.

Key Duties & Accountabilities:

  • Development of scaleable 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; execute studies together with junior members
  • 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
  • Authoring documents, including technical reports, SOPs, and experimental protocols
  • Serve as PD representative and participate in both internal and external manufacturing meetings
  • Contribute to scale up activities and draft tech transfer related documents (e.g. process descriptions and process flow diagrams)
  • Conduct facility fit exercise
  • Review batch records and provide feedback
  • Support manufacturing floor activities
  • Provide technical support (e.g. process/operational gap identification and troubleshooting) to manufacturing group
  • Support Solid’s Quality Assurance team to help evaluate deviations, CAPA, and Change Controls (both internal and external)
  • Support regulatory filings and responses to agency
  • Performs other related duties and ad hoc projects as required by position

Core Competencies Required:

  • Self-motivated, accountable, inquisitive, with excellent organizational and communication skills
  • Flexibility to switch between projects
  • Ability to lead/manage junior team members

Knowledge: Education, Experience, & Skills:

  • PhD in a scientific discipline or equivalent and 5-8 years’ experience OR Masters’ degree and 8+ years, OR BS and 10+ years related experience; may include post-doctoral experience
  • Experience in purification process development, scale-up and scale down, as well as technical transfer
  • Solid theoretical basis and hands-on experience in protein purification and analytical characterization
  • Hands-on experience with purification unit operations including filtration, different mode chromatography, TFF, UF/DF, AKTA, UNICORN, and HPLC systems  

Travel Commitment:

  • Up to 30% travel may be required at times
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  • Location
    Cambridge, Massachusetts
  • Department
    306 - Process Development
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced
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