Position:  Senior Scientist, Analytical Development: Chromatography
Location:  Cambridge, MA
Job Id:  015
# of Openings:  1

Summary:
 
Solid Biosciences is looking to hire a Senior Scientist to lead a group of junior level scientists and function as a senior member of the analytical development department. This person will lead the development and execution of studies to characterize Solid Biosciences’ leading candidate, an adeno-associates virus (AAV) based gene therapyproduct for the treatment of Duchenne Muscular Dystrophy (DMD) using chromatography methods to support product characterization, formulation development, process development, and manufacturing.
 
Key Duties & Responsibilities:
  • Functions independently as technical expert in chromatography method development, execution and trouble shooting including but not limited to (HPLC, RP-HPLC, IEX-HPLC ce-SDS, cIEF (R, NR) AUC, DLS· Use of Empower Software
  • Plans and reviews own weekly/monthly activities for team with input in accordance with group/lab objectives and priorities
  • Participates in weekly Sr. Staff meetings
  • Perform routine analytical testing in support of process development in process 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
  • 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 in analytical development within a biotech/pharmaceutical analytical development and/or Quality Control environment required
  • Must have experience with biological products; Gene therapy experience a plus
  • Theoretical and hands-on knowledge and experience with chromatography methods used for biopharmaceutical characterization and routine testing and impurity identification
  • Experience working in cGMP supporting analytical development / Quality Control environment with an understanding of regulatory requirements and trends related to product quality 
  • Experience in late stage development of biologics 
  • Experience in writing technical documents 
  • Good understanding of compliance and cGMP considerations 
 
Travel:
  • Some travel may be required

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