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Solid Biosciences

Associate/Senior Associate Scientist, Analytical Development - Chromatography

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

Summary:

The Associate/Senior Associate Analytical Development will be responsible for analytical development, qualification, and operational support for chromatography, capillary electrophoresis, ELISA, and other relevant techniques to support Preclinical, Phase I through Phase III for clinical products for Solid Biosciences. Solid Biosciences’ leading candidate is an adeno-associates virus (AAV) based gene therapy product for the treatment of Duchenne Muscular Dystrophy (DMD).

Key Duties & Accountabilities:

  • Execute experiments in support of HPLC, CE-SDS, ELISA, and other relevant biological analytic method development and optimization, with guidance from internal management
  • Participate in method qualification/validation and method transfer studies
  • Provide support to QC investigations through experimental design, data mining, and analysis, problem solving, and technical writing
  • Lab operation: routine and non-routine analytical testing, coordination with internal/external PD or cGMP Manufacturing, maintain laboratory equipment, maintain laboratory inventory, compile and present data to support process development and stability
  • Optimize, qualify, monitor performance, and maintain inventory of assay specific Reference Standards and Critical Reagents used in Quality Control Bioassays
  • Create technical protocols and reports for Critical Reagents and Reference Standards
  • Trend and report method and Critical Reagents performance data
  • Maintain well documented records of analytical data, laboratory notebooks, execution of assays, and stability data
  • Performs other related duties and ad hoc projects as required by position

Competencies Required:

  • Experience in development and optimization of chemistry and chromatography assays, such as HPLC and CE-SDS
  • Working knowledge of ELISA, biomolecular assays, such as qPCR or ddPCR, and virology preferred
  • Excellent communication, technical, and organizational skills required
  • Must be a team player prepared to work in, and embrace a team-based culture
  • Proven troubleshooting, technical writing, problem solving, and investigational skills

Knowledge: Education, Experience, & Skills:

  • Bachelor's degree or equivalent with at least 2+ years of relevant experience, or master’s degree
  • Experience in HPLC, CE-SDS, ELISA, and other techniques such as qPCR and ddPCR
  • Problem solving and troubleshooting skills, along with proficiency in data analysis, and lab documentation
  • Understanding of compliance and cGMP considerations

Travel Commitment:

  • Some travel may be required
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  • Location
    Cambridge, Massachusetts
  • Department
    306 - Process Development
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level
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