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, this individual supports development activities and technical projects to characterize gene therapy products using a range of analytical methods. The role contributes to cross-functional efforts to monitor and characterize processes and products, identify continuous-improvement opportunities, and support delivery of gene therapy to patients. A growth mentality and passion for serving patients, the technical team, and development programs are essential. The position contributes to project and network strategy, applies scientific, technical, GMP, and quality expertise to complex R&D issues, and supports global technical strategies. It includes designing, performing, interpreting, and reporting scientific experiments and GMP testing; developing, validating, and implementing analytical methods; maintaining and qualifying assigned lab equipment and infrastructure; and supporting clinical and commercial manufacturing development. The successful candidate drives project deliverables, communicates technical challenges and data, prepares and reviews technical documentation, and stays current with analytical technology advances relevant to cell and gene therapy. This is a dual-level posting. Candidates will be assessed for Expert or Senior Expert level based on their knowledge and experience. The position is based onsite in East Hanover; relocation support is not available. Flexible and hybrid working options may be offered where possible.

Requirements

For Expert level: bachelor’s degree in biology, biochemistry, molecular biology, immunology, or a related scientific discipline and 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 and more than 4 years of prior industry experience.
Established experience with analytical method development and validation for cell-based and other plate-based assays using platforms such as PCR, ELISA, flow cytometry, MSD, high-content imaging, and luminescent or fluorescent plate readers.
Strong scientific background and understanding of gene therapy, cell biology, and drug product development.
Ability to work collaboratively in a fast-paced team environment and quickly acquire new technical skills and knowledge.
Excellent organizational, communication, and scientific/technical writing skills.

Nice To Haves

For Expert level, preferred experience: bachelor’s degree with more than 5 years, master’s degree with more than 2 years, or Ph.D. with more than 1 year of experience.
For Senior Expert level, preferred experience: bachelor’s degree with more than 5 years, master’s degree 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 implementation, applying scientific, technical, GMP, and quality expertise to complex R&D issues within multifunctional project teams.
Work with and coach team members, contribute to global technical strategies and goals, and maintain and qualify equipment and infrastructure while managing assigned laboratory operations.
Design, plan, perform, interpret, and report scientific experiments, GMP testing, or pilot plant processes for timely preparation and delivery of drug substances, drug products, processes, or procedures.
Design, plan, and perform product-characterization studies using cell-based and other plate-based assays and platforms such as ELISA, MSD, high-content imaging, and luminescent or fluorescent plate readers.
Identify, develop, validate, and implement novel analytical assays and 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 advance science-driven, 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 in accordance with applicable GMP/GLP regulations, Novartis SOPs and guidelines, and the Code of Conduct.
Perform other related duties as assigned.