Senior Expert Science & Technology - Mass Spectrometry - Gene Therapy Analytical Development - [...]

Role Purpose As a key member of the Analytical Development team, this individual will support developmental activities to aid in delivering gene therapy to patients. The successful candidate will support technical and development projects designed to characterize gene therapy products with a technical focus on leveraging mass spectrometry. Summary Location: East Hanover, US #onsite About The Role This role will leverage deep Mass Spectrometry expertise to contribute to cross‑functional activities including monitoring and characterizing of processes and products as well as to identify opportunities for continuous improvement. Growth mentality and passion to serve patients, technical teams, and development programs is a must. Key Responsibilities Design, plan, and perform product characterization studies utilizing a deep understanding of protein mass spectrometry. This includes optimizing and implementing experimental and routine analyses using methodologies like peptide mapping for PTM determination, intact and middle down MS for variant identification, and quantitative methods such as TMT labeling and label‑free quantitation. Competitive candidates will also have a working understanding of chromatography (HPLC), capillary electrophoresis (CE), and other biophysical assays for the characterization and lot release/stability monitoring of gene therapy products. Contribute to all project/network strategy and drive the implementation; apply scientific/technical/GMP and/or quality‑related expertise to address complex R&D 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. 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. Actively keep ahead of the latest advances in analytical technologies for cell and gene therapy. Essential Requirements Bachelor’s degree in Analytical Chemistry, Biology, Biochemistry, Molecular Biology, Immunology or related scientific discipline with > 5 years of prior experience in industry required. BS with > 6 years, MS with > 4 years and Ph.D. with > 2 years experience preferred (Ph.D. preferred). State‑of‑the‑art principles and theories in protein mass spectrometry, analytical chemistry, protein chemistry, DNA chemistry, and related disciplines. Experience working with AAV, LVV analytics preferred. Experience utilizing high‑resolution MS is required, experience with Thermo Tribrid MS instrument highly valued. Strong working knowledge on analytical software including but not limited to Byos, Proteome Discoverer, BioPharmaFinder, and Xcalibur, as well as basic understanding of Chromeleon, Empower, Chemstation, and 32Karat for chromatographic systems. Strong scientific background and understanding of gene therapy, cell biology and drug product development. Demonstrated ability to work collaboratively in a fast‑paced team environment and quickly acquire new technical skills and knowledge. Pay range for this position at commencement of employment is expected to be between $108,500 – $201,500 per year. The total compensation package may also include sign‑on bonus, restricted stock units and discretionary awards in addition to a full range of medical, financial and other benefits (including 401(k) eligibility and various paid time off such as vacation, sick time and parental leave). EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please send an e‑mail to [email protected] or call View phone number on click.appcast.io. #J-18808-Ljbffr Novartis