Senior Expert, Gene Therapy Analytical Development Chemistry

Role Summary

Senior Expert, Gene Therapy Analytical Development Chemistry. Key member of Analytical Development supporting developmental activities to aid in delivering gene therapy to patients. Contributes to characterization of gene therapy products through analytical methods and cross-functional activities to identify opportunities for continuous improvement.

Responsibilities

• Contribute to project/network strategy; apply GMP/quality-related expertise to address complex technical issues within a multifunctional project team.
• Coach team members; maintain/qualify equipment and manage lab operations as assigned.
• Design, plan, perform, interpret and report experiments for the preparation and delivery of drug substances/products, processes or procedures.
• Design and perform product characterization studies using chromatography (HPLC), CE, MS and other assays for characterization and lot release/stability monitoring; identify, develop, validate and implement novel analytical assays and GMP-compliant methodologies.
• Drive project timelines and deliverables while meeting quality and data integrity requirements.
• Resolve technical challenges, communicate effectively, and present data within the department and cross-functionally.
• Author/review method development reports, SOPs, validation reports and technical documents for regulatory filings.
• Contribute to analytical development for clinical and commercial manufacturing; advance science-driven methodologies.
• Identify new technologies and instrumentation to improve workflows; stay ahead of advances in analytical technologies for cell and gene therapy.
• Work according to GMP/GLP regulations and company SOPs and Code of Conduct.

Qualifications

• Essential: Bachelor’s degree in Analytical Chemistry, Biology, Biochemistry, Molecular Biology, Immunology or related field with >4 years of industry experience; advanced degrees with corresponding years preferred.
• Strong knowledge of analytical chemistry, protein/nucleotide chemistry; understanding of gene therapy and drug product development.
• Proficiency with analytical software (e.g., Chromeleon, Empower, Chemstation, Astra, 32Karat, Xcalibur, Mascot, Byonic).
• Collaborative, fast-paced team player; ability to quickly acquire new technical skills.
• Innovative mindset; ability to evaluate alternative approaches and keep up with literature developments.
• Excellent organizational, communication, and scientific/technical writing skills; ability to translate ideas into work processes.

Desirable Qualifications

• Experience with AAV, LVV analytics.
• Experience with IND/BLA dossier authoring and responding to agency questions.

Education

• Not specified beyond degree requirements in Essential Qualifications.