Senior Expert, Gene Therapy Analytical Development Chemistry

Role Summary

As a key member of the Analytical Development team, the candidate will support development activities to aid in delivering gene therapy to patients. They will support technical and development projects to characterize gene therapy products using a range of analytical methods. The role also contributes to cross-functional activities including monitoring and characterizing processes and products to identify opportunities for continuous improvement. A growth mindset and passion to serve patients, the technical team, and development programs are essential.

Responsibilities

• Contribute to all project/network strategy and drive the implementation; apply scientific/technical/GMP and/or quality-related expertise to address complex technical issues within a multifunctional project team.
• Coach team members and contribute to global technical strategies and goals; maintain and qualify equipment/infrastructure and manage operational aspects in lab as assigned.
• Design, plan, perform, interpret and report scientific experiments or testing for the preparation and timely delivery of drug substances (DS), drug products (DP), processes or procedures.
• Design, plan, and perform product characterization studies using chromatography (HPLC), capillary electrophoresis (CE), mass spectrometry (MS) based and other biophysical/biochemical assays for the characterization and lot release/stability monitoring of gene therapy products; identify, develop, validate and implement novel analytical assays and new GMP-compliant methodologies for pipeline gene therapy products.
• Drive project timelines and deliverables while meeting internal quality and data integrity requirements.
• Implement resolution to technical challenges, communicate effectively and present complex data within the department and cross-functionally.
• Author and/or review method development reports, SOPs, validation reports and technical documents for regulatory filings.
• Actively contribute to analytical development for clinical and commercial manufacturing and assist in advancing science-driven and innovative methodologies.
• Independently identify new scientific technologies and instrumentation with the potential to improve development workflows; stay ahead of the latest advances in analytical technologies for cell and gene therapy.
• Work according to appropriate GMP/GLP regulations and Novartis SOPs/Guidelines and Code of Conduct.

Qualifications

• Required: Bachelor’s degree in Analytical Chemistry, Biology, Biochemistry, Molecular Biology, Immunology or related scientific discipline with more than four years of prior industry experience; a BS with more than five years, MS with more than four years, and Ph.D. with more than three years of experience is preferred.
• Required: state-of-the-art principles and theories in analytical chemistry, protein chemistry, nucleotide chemistry and related disciplines.
• Required: strong scientific background and understanding of gene therapy, cell biology and drug product development.
• Required: strong working knowledge of analytical software including but not limited to Chromeleon, Empower, Chemstation, Astra, 32Karat, Xcalibur, Mascot, Byonic.
• Required: demonstrated ability to work collaboratively in a fast-paced team environment and quickly acquire new technical skills and knowledge.
• Required: drives innovation by researching relevant literature to improve existing methodologies while evaluating alternative approaches.
• Required: excellent organizational, communication and scientific/technical writing skills.
• Required: facilitates the incorporation of ideas from conferences or literature into work processes.
• Preferred: experience working with AAV and LVV analytics.
• Preferred: experience with IND/BLA dossier authoring and responding to agency questions.

Skills

• Analytical instrumentation and method development
• Data interpretation and scientific reporting
• Cross-functional collaboration and project leadership
• Scientific/technical writing