Expert/Senior* Expert Gene Therapy Analytical Development - Bioassay

Job Description Summary

As a key member of the Analytical Development Bioassay 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 through an assortment of analytical methods. This role will also contribute to cross-functional activities including monitoring and characterizing of processes and products to identify opportunities for continuous improvement. Growth mentality and passion to serve patients, his/her technical team and development programs is a must.

 

Job Description

#LI-Onsite  

This role is based in East Hanover. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.  

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 through an assortment of analytical methods. This role will also contribute to cross-functional activities including monitoring and characterizing of processes and products to identify opportunities for continuous improvement. Growth mentality and passion to serve patients, his/her technical team and development programs is a must.

What you will be doing;

• 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.
• Work with/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 GMP testing or pilot plant processes for the preparation and timely delivery of drug substances (DS), drug products (DP), processes or procedures.
• Design, plan, and perform product characterization studies using cell-based assays and other plate-based assays using variety of platforms including ELISA, MSD, high-content imaging and luminescent/fluorescent plate reader
• 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 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.  
• Other related job duties as assigned. 

What you will bring to the role;

• For Expert level: Bachelor's degree in biology, Biochemistry, Molecular Biology, Immunology or related scientific discipline with > 2 years of prior industry experience required. BS with > 5 years, MS with >2 years, Ph.D. with >1 year experience preferred  
• For Sr. Expert level: Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Immunology or related scientific discipline with > 4 years of prior experience in industry required. BS with > 5 years, MS with > 4 years and Ph.D. with > 3 years experience preferred
• Established experience with analytical method development and validation for cell-based assays and other plate-based assays using variety of platforms including PCR, ELISA, flow cytometry, MSD, high-content imaging and luminescent/fluorescent plate reader
• 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  
• Drives innovation by researching relevant litera