Expert/Senior Expert Gene Therapy Analytical Development - Bioassay

Novartis•East Hanover, NJ

5d•$93,800 - $222,300•Onsite

About The Position

As a key member of Novartis’s Analytical Development Bioassay team, the Expert/Senior Expert supports development activities that help deliver gene therapy products to patients. The role contributes to technical and development projects that characterize gene therapy products through analytical methods, as well as cross-functional efforts to monitor and characterize processes and products and identify opportunities for continuous improvement. A growth mentality and commitment to patients, the technical team, and development programs are essential. The position is based onsite in East Hanover, New Jersey. Novartis is unable to offer relocation support. This is a dual-level posting; candidates will be assessed for both levels based on their knowledge and experience. The successful candidate will contribute to project and network strategy, apply scientific, technical, GMP, and quality expertise to complex R&D issues, and support team members and global technical goals. The role designs, performs, interprets, and reports scientific experiments and GMP testing; develops and validates analytical methods; supports clinical and commercial manufacturing; and authors or reviews technical documents. The candidate is expected to keep abreast of analytical technology advances relevant to cell and gene therapy and to work in accordance with applicable GMP/GLP regulations, Novartis procedures, guidelines, and Code of Conduct.

Requirements

For Expert level: Bachelor’s degree in biology, biochemistry, molecular biology, immunology, or a related scientific discipline, with more than 2 years of prior industry experience.
For Senior Expert level: Bachelor’s degree in biology, biochemistry, molecular biology, immunology, or a related scientific discipline, with more than 4 years of prior industry experience.
Established experience developing and validating analytical methods for cell-based and other plate-based assays using platforms such as 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.
Ability to collaborate in a fast-paced team environment and quickly acquire technical skills and knowledge.
Excellent organizational, communication, and scientific/technical writing skills.
Work in accordance with appropriate GMP/GLP regulations and company procedures, guidelines, and Code of Conduct.

Nice To Haves

For Expert level, preferred experience: BS with more than 5 years, MS with more than 2 years, or Ph.D. with more than 1 year of experience.
For Senior Expert level, preferred experience: BS with more than 5 years, MS with more than 4 years, or Ph.D. with more than 3 years of experience.
Experience with AAV and LVV analytics.
Knowledge of using AI in daily activities.
Research relevant literature to improve existing methodologies and evaluate alternative approaches.
Facilitate incorporating ideas from conferences or literature into work processes.

Responsibilities

Contribute to project and network strategy and drive its implementation, applying scientific, technical, GMP, and quality-related expertise to complex R&D issues within multifunctional project teams.
Work with and coach team members, contribute to global technical strategies and goals, maintain and qualify equipment and infrastructure, and manage assigned laboratory operations.
Design, plan, perform, interpret, and report scientific experiments, GMP testing, or pilot plant processes for the preparation and timely delivery of drug substances, drug products, processes, or procedures.
Design, plan, and perform product characterization studies using cell-based and other plate-based assays, including platforms such as 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.
Resolve 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.
Contribute to analytical development for clinical and commercial manufacturing and help advance science-driven and innovative methodologies.
Identify scientific technologies and instrumentation that could improve development workflows, and stay current with advances in analytical technologies for cell and gene therapy.
Work according to appropriate GMP/GLP regulations, Novartis SOPs and guidelines, and the Novartis Code of Conduct.
Perform other related duties as assigned.