Expert/Senior* Expert Gene Therapy Analytical Development - Bioassay

About the Role

This role is based in East Hanover. Novartis is unable to offer relocation support for this role. 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 processes and products to identify opportunities for continuous improvement. A growth mentality and passion to serve patients, the technical team, and development programs is essential.

Responsibilities

• 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 the 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 a variety of platforms including ELISA, MSD, high-content imaging, and luminescent/fluorescent plate readers.
• 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.
• Perform other related job duties as assigned.

Requirements

• For Expert level: Bachelor's degree in Biology, Biochemistry, Molecular Biology, Immunology, or related scientific discipline with more than 2 years of prior industry experience required. BS with more than 5 years, MS with more than 2 years, or Ph.D. with more than 1 year of experience preferred.
• For Sr. Expert level: Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Immunology, or related scientific discipline with more than 4 years of prior industry experience required. BS with more than 5 years, MS with more than 4 years, or Ph.D. with more than 3 years of experience preferred.
• Established experience with analytical method development and validation for cell-based assays and other plate-based assays using a variety of platforms including PCR, ELISA, flow cytometry, MSD, high-content imaging, and luminescent/fluorescent plate readers.
• 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 literature to improve existing methodologies while evaluating alternative approaches.
• Excellent organizational, communication, and scientific/technical writing skills.
• Facilitates the incorporation of ideas from conferences or literature into work processes.
• Experience working with AAV, LVV analytics preferred.
• Knowledge of using AI in daily activities is a plus.

This is a dual-level posting, and candidates will be assessed for both levels based on their knowledge and experience.

Benefits

At Novartis, we’re committed to reimagining medicine together—and rewarding the people who make it happen. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

• Insurance plans, retirement plans, and wellbeing resources.
• Global recognition programs.
• Flexible and hybrid working options, where possible.
• Minimum 14 weeks paid parental leave.

Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package will be communicated during the application process.

Pay

Expected Annual Base Salary Range for role at Expert and Senior Expert levels:

• Expert (level 3): $93,800.00 – $134,000.00 – $174,200.00
• Senior Expert (level 4): $119,700.00 – $171,000.00 – $222,300.00

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies, and experience in accordance with the Novartis pay-setting policy and will be reviewed periodically upon joining Novartis.