Senior Scientist, Analytical Development

Senior Scientist, Analytical DevelopmentReports to (title):Head of Analytical SciencesSolid Summary:Solid Biosciences is a biotechnology company focused on advancing a portfolio of neuromuscular and cardiac AAV mediated gene therapy programs, including SGT-003, for the treatment of Duchenne muscular Dystrophy (DMD). SGT-212, for the treatment of Friedreichs Ataxia (FA), SGT-501, for the treatment of cardiac polymorphic ventricular tachycardia (CPVT) and SGT-601, for the treatment of dilated cardiomyopathy. 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, Solids mandate is to improve the daily lives of patients living with these devastating diseases.Position Summary:The Senior Scientist, Analytical Development will be responsible for development and prequalification of molecular and biochemical assays to support Process and Preclinical Development. Additionally, this role functions as SME supporting Solids Clinical Programs at various CROs and CMOs. This role is expected to drive technological advancements within Solids Analytical Development function as well as influence and execute on the overall analytical strategy. Managerial responsibilities include leading and developing a team of several analysts, schedule and support routine testing activities and data reviewKey Duties & Accountabilities:Plan, schedule, conduct, and coordinate all phases of analytical assay development with a focus on AAV molecular characterization. Work independently and efficiently on routine analytical development and testing assignmentsWork closely with the AS&T function on technology transfer of analytical methods, protocols/procedures from internal labs to CMOs/CTOs, or between CMOs/CTOs Provide direction to members of cross-functional teams, setting timelines and providing feedback to management on performance against key milestonesDiscuss changes, progress, and scientific issues as it relates to the analytical development group, to cross functional and outside partners Trend and report method and critical reagents performance data Possess curiosity and desire to learn in area of expertise, take ownership of personal career development needsOversee and guide non-routine technical work and general development of associate scientists and scientists within the teamAuthor and review SOPs, protocols, reports, impact assessments and root cause analyses.Work effectively in cross functional program teams Provide support with regulatory submissions (IND/BLA)Core Competencies Required:InclusiveEmpoweredCollaborativeResilientFocusedKnowledge: Education, Experience, & Skills:BS/MS with 8+ years or Ph.D. with 5+ years relevant industry experience with a degree in Biology, Chemistry, Chemical/Biochemical Engineering or related scientific disciplineMust have extensive hands-on experience with molecular and biochemical assays, including but not limited to (d)dPCR, qPCR, ELISA/MSD, and deep knowledge of the underlying technical principlesMust have experience in applying international (e.g. ICH) and national regulations and guidelines (USP/EP) related to analytical assay development, and qualification of analytical methodsMust have experience managing a team of associates and associate scientistsMust have excellent attention to detailMust have excellent communication skills and ability to build key networks and business relationships across all of Solids departmentsExperience with NGS long and short read workflows is desiredExperience authoring and reviewing CMC sections of Regulatory Filings is desired Travel Commitment:Anticipate Occasional travel for on-site visits to external suppliers and company meetingsRole Location (HQ, Hybrid, Remote, NC, etc.)Charlestown HQ, On-site 60-80%, Hybrid