Position:  Senior Scientist, Analytical Development: Mass Spectrometry
Location:  Cambridge, MA
Job Id:  011
# of Openings:  1

Summary:
 
Solid Biosciences is looking to hire a Senior Scientist/Scientist, Mass Spectrometry. This individual will lead the development and execution of studies to characterize Solid Biosciences’ leading candidate, an adeno-associates virus (AAV) based gene therapy product for the treatment of Duchenne Muscular Dystrophy (DMD) by mass spectrometry HPLC, light scattering, etc, to support product characterization, formulation development, process development, and manufacturing.
 
Key Duties and Responsibilities:
  • Functions independently as technical expert in Mass spectrometry to develop, execute and troubleshoot experiments for LC-MS and LC-MS/MS based assays to assess in process and drug product samples (eg. Peptide mapping, intact molecular weight analysis)
  • Use of Thermo MS Software· Plans own weekly/monthly activities with input in accordance with group/lab objectives and priorities
  • Perform routine analytical testing in support of process development activities in house and product characterization
  • Analytical Development: support the development of new methods by identifying, evaluating and executing analytical methods to support ongoing analytical needs (Knowledge of CDMS and methods for residual DNA analysis a plus)
  • GMP manufacturing: participate in the support of analytical activities at CMOs and CTOs related to analytics including method qualification and validation, data trending, troubleshooting, optimization, review and reporting
  • Management of external resources: assist in the execution of analytical development activities at CTOs and CMOs, including deliverables and timelines; participate in tech transfer of intellectual property, protocols/procedures and know-how from internal labs to QC and CMOs/CTOs, or between CMOs/CTOs
  • Participate in BLA-enabling activities including product and process characterization, comparability studies, CQA assessment activities
  • Author and/or critically review key documents such as: comparability protocols, methods and reports
  • Assist in review and writing of regulatory filings including IND/IMPD and BLA
  • Collaborate with process development, QA and QC functions to ensure strong cross functional collaborations and integrated process and product development and characterization
  • Build the scientific knowledge, capabilities, and strategies in gene therapy product characterization that enable fast to clinic/fast to market product development and commercialization.
  • Defines science-driven, phase appropriate, and risk-based analytical development strategies to support the candidate from clinical development and commercial manufacture
 
Competencies Required:
  • Excellent communication, technical and organizational skills are required
  • Must be a team player prepared to lead, work in, and embrace a team-based culture
  • Proven troubleshooting, technical writing, problem solving and investigational skills
 
Education, Experience & Skills:
  • Ph.D. in chemistry, biology, biochemistry or related field and 4+ years of experience or Masters’ degree and 6+ years’ experience. Bachelor degree in chemistry, biology, biochemistry or related field and 8+ years’ experience in analytical development within a biotech/pharmaceutical analytical development and/or Quality Control environment required
  • Theoretical and hands-on knowledge and experience with mass spectrometry methods used for biopharmaceutical characterization and impurity identification including intact mass analysis, peptide mapping Travel: Occasional travel required
Travel: 
  • Occasional travel required 

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