Senior Expert Science & Technology - Mass Spectrometry - Gene Therapy Analytical Development - Chemistry
Novartis
June 27, 2026
On-site
East Hanover, NJ
Clinical Research and Development
Role Purpose
- Support developmental activities to characterize gene therapy products using a technical focus on mass spectrometry.
- Leverage deep Mass Spectrometry expertise for monitoring/characterizing processes and products; identify continuous improvement opportunities.
Key Responsibilities
- Design, plan, and perform product characterization studies using protein mass spectrometry (optimize experimental/routine analyses; peptide mapping for PTMs, intact/middle-down MS for variants, quantitative methods like TMT labeling and label-free quantitation).
- Use chromatography (HPLC), capillary electrophoresis (CE), and other biophysical assays for characterization and lot release/stability monitoring.
- Contribute to project/network strategy; apply scientific/technical/GMP/quality expertise to address complex R&D issues.
- Coach team members; contribute to global technical strategies; maintain/qualify equipment/infrastructure and manage lab operations as assigned.
- Identify, develop, validate, and implement novel analytical assays and GMP-compliant methodologies.
- Drive project timelines/deliverables with quality and data integrity.
- Resolve technical challenges; communicate and present complex data cross-functionally.
- Author/review method development reports, SOPs, validation reports, and technical documents for regulatory filings.
- Contribute to analytical development for clinical/commercial manufacturing.
- Identify new technologies/instrumentation to improve workflows; stay current on advances in analytical technologies for cell and gene therapy.
Essential Requirements
- BS in relevant field with >5 years industry experience (or MS with >4 years; PhD with >2 years).
- Strong knowledge of protein mass spectrometry and analytical/protein/DNA chemistry; AAV/LVV analytics preferred.
- High-resolution MS experience (Thermo Tribrid MS highly valued).
- Proficiency with analytical software (e.g., Byos, Proteome Discoverer, BioPharmaFinder, Xcalibur) and basic familiarity with Chromeleon/Empower/Chemstation/32Karat.
- Background in gene therapy, cell biology, and drug product development.
- Ability to work collaboratively in a fast-paced environment and learn new technical skills quickly.
- Support developmental activities to characterize gene therapy products using a technical focus on mass spectrometry.
- Leverage deep Mass Spectrometry expertise for monitoring/characterizing processes and products; identify continuous improvement opportunities.
Key Responsibilities
- Design, plan, and perform product characterization studies using protein mass spectrometry (optimize experimental/routine analyses; peptide mapping for PTMs, intact/middle-down MS for variants, quantitative methods like TMT labeling and label-free quantitation).
- Use chromatography (HPLC), capillary electrophoresis (CE), and other biophysical assays for characterization and lot release/stability monitoring.
- Contribute to project/network strategy; apply scientific/technical/GMP/quality expertise to address complex R&D issues.
- Coach team members; contribute to global technical strategies; maintain/qualify equipment/infrastructure and manage lab operations as assigned.
- Identify, develop, validate, and implement novel analytical assays and GMP-compliant methodologies.
- Drive project timelines/deliverables with quality and data integrity.
- Resolve technical challenges; communicate and present complex data cross-functionally.
- Author/review method development reports, SOPs, validation reports, and technical documents for regulatory filings.
- Contribute to analytical development for clinical/commercial manufacturing.
- Identify new technologies/instrumentation to improve workflows; stay current on advances in analytical technologies for cell and gene therapy.
Essential Requirements
- BS in relevant field with >5 years industry experience (or MS with >4 years; PhD with >2 years).
- Strong knowledge of protein mass spectrometry and analytical/protein/DNA chemistry; AAV/LVV analytics preferred.
- High-resolution MS experience (Thermo Tribrid MS highly valued).
- Proficiency with analytical software (e.g., Byos, Proteome Discoverer, BioPharmaFinder, Xcalibur) and basic familiarity with Chromeleon/Empower/Chemstation/32Karat.
- Background in gene therapy, cell biology, and drug product development.
- Ability to work collaboratively in a fast-paced environment and learn new technical skills quickly.