Sr Scientist, Analytical Development

Solid Biosciences

Solid Biosciences

Charlestown, Boston, MA, USA
Posted on Friday, December 22, 2023
Sr Scientist, Analytical Development
Solid Summary:
Solid Biosciences is a life science company focused on advancing a portfolio of neuromuscular and cardiac programs, including SGT-003, a differentiated gene therapy candidate for the treatment of Duchenne, AVB-401, a gene therapy program for the treatment of BAG3 mediated dilated cardiomyopathy, AVB-202-TT, a gene therapy program for the treatment of Friedreich’s Ataxia, and additional assets for the treatment of fatal cardiac diseases. Solid aims to be the center of excellence across a given disease spectrum bringing together those with expertise in science, technology, disease management, and care. Patient-focused and founded by those directly impacted, Solid’s mandate is to improve the daily lives of patients living with these devastating diseases.
Position Summary:
Solid Biosciences is looking to hire a Sr Scientist to support the Analytical Development team. This individual would be responsible for analytical cell-based assay development, qualification, and operational support for Preclinical, Phase 1 and Phase 3 of 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) and a evolving portfolio of gene therapies for cardiac indications.
Essential Functions / Key Responsibilities:
  • Support the development and execution of cell-based assay development for Solid Biosciences gene therapy portfolio.
  • Lab operation: routine and non-routine cell based and molecular testing, coordination with internal/external PD or cGMP Manufacturing, compile, and present data to support process development and stability.
  • Lead the development of new cell based and molecular methods by identifying, evaluating, qualifying, validating, and executing analytical methods to support ongoing analytical needs.
  • Participate in the support of GMP manufacturing activities at CMOs and CTOs related to analytics including coordinating testing, shipments, inventory, data review and reporting.
  • Support ongoing regulatory filings and interactions including IND, CTA and BLA.
  • Maintain well documented records of analytical data, laboratory notebooks.
  • Act as subject matter expert and involved in updates to Operational and Senior Management teams.
  • Recruit and train junior scientists for cell-based analytical method development.
  • Technology Transfer: Participate in tech transfer of analytical methods, protocols/procedures, and know-how from internal labs to CMOs/CTOs, or between CMOs/CTOs. Act as subject matter expert to support external analytical qualification and validation activities.
  • Maintain up to date knowledge of cell-based assay and potency assay development requirements especially in the areas of gene therapy for neuromuscular and cardiac indications.
Basic Qualifications:
  • Ph.D. in Microbiology, Biology, Genetics or related field and 3+ years of experience in analytical development or BS/MS in related field with 7+ years of experience.
  • Proficient in molecular and cell based analytical methods including cell culture, In vitro cell based assays, ddPCR, ELISA, and flow cytometry.
  • Proficiency in statistical methods for analytical assay performance, qualification, and trending
  • Proven ability to develop cell-based potency assays in an industrial environment.
  • Experience with Cardiac or muscle biology preferred.
  • Experience working in cGMP supporting analytical development environment with an understanding of Quality and regulatory requirements.
  • Experience with Electronic Lab Notebook (ELN)
  • Understanding of compliance and cGMP considerations
Years of Experience:
  • 3-7+ years
Preferred Qualifications:
  • Excellent communication, technical and organizational skills are required.
  • Must be a team player prepared to work in and embrace a team-based culture.
  • Proven troubleshooting, problem solving and investigational skills.
Travel Commitment:
  • Some travel may be required.