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Solid Biosciences

Senior Scientist/Senior Engineer

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

Summary:

Solid Biosciences is seeking an experienced and highly motivated Scientist or Engineer to join the Upstream Process Development team to lead tech transfer activities for transfer of clinical and commercial scale upstream processes to internal and external partners. The position is also responsible for providing technical leadership around bioreactor scale-up and process characterization activities.

Key Duties & Accountabilities:

  • Lead and manage multiple projects as upstream tech transfer representative including fit-to-plant, process risk analysis, batch record review/approval, managing technical relationships, internal and external teams, campaign monitoring and support, performance analysis and interpretation, investigation support
  • Builds and maintains relationships with partner groups
  • Generate tech transfer documentation
  • Represent upstream process development group on cross-functional teams
  • Lead lab-scale experimentation to support process changes, generate robustness data, and/or resolve manufacturing deviations
  • Lead lab-scale experimentation to support characterization of bioreactor scale-up parameters such as mixing and gas transfer
  • Provide input on process development strategies
  • Write technical reports and deliver presentations
  • Work closely with internal/external manufacturing teams on process troubleshooting and improvement
  • Additional duties and responsibilities as required

Core Competencies Required:

  • Skilled in root cause analysis and problem-solving
  • Demonstrated critical thinking skills
  • Excellent written and verbal communication skills
  • Sound decision making with limited data and guidance
  • Demonstrated initiative and drive for results
  • Must be able to work independently
  • Experience with data and statistical analysis
  • Proven experience in preparing detailed and thorough technical protocols and reports

Knowledge: Education, Experience, & Skills:

  • Degree in process engineering or scientific discipline (e.g. chemical or biochemical engineering) with an appropriate amount of relevant industry experience (PhD 4+ years, MS 6+ years, BS 10+ years)
  • Upstream tech transfer and development experience
  • Hands on experience with bioreactors (bench and pilot/production scale)
  • Fundamental understanding of upstream unit operations
  • Demonstrated knowledge of the scale-up/scale-down principles of cell culture processes
  • Knowledge of GMP manufacturing principles and documentation
  • Experience with Microsoft Office Suite

Travel Commitment:

  • Domestic travel (up to 15%) to CMO/partner sites may be required
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  • Location
    Cambridge, Massachusetts
  • Department
    306 - Process Development
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced
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