Associate Scientist/Scientist, LNP Formulation & Process Development

Position Overview

The Associate Scientist/Scientist, LNP Process Development will lead the formulation and process development of lipid nanoparticles (LNPs) for RNA delivery across multiple therapeutic programs. This role is central to NATi’s translational strategy, enabling robust and scalable LNP process development and supporting clinical advancement via seamless technology transfer. The successful candidate will establish robust, scalable, and reproducible LNP manufacturing processes using Quality by Design (QbD) principles, supporting production from early-stage research through preclinical and pilot-scale batches. The successful candidate will also drive technology transfer to external CDMOs, ensuring alignment with regulatory and quality standards for clinical development.

Key Responsibilities

• Develop and optimize LNP formulation processes for different RNA payloads (e.g., mRNA, circRNA, saRNA, gRNA), focusing on encapsulation efficiency, particle size control, and stability.
• Design and implement high-throughput, automated workflows for LNP formulation and purification, leveraging scalable technologies (e.g., microfluidics, TFF systems) to support rapid screening, process optimization, and multiscale production (mg to gram) from discovery through pilot-scale manufacturing.
• Apply QbD principles to define critical process parameters (CPPs) and critical quality attributes (CQAs) for LNP manufacturing workflows.
• Integrate process analytical technologies (PAT) for real-time monitoring and control of LNP manufacturing workflows.
• Design and execute process development studies coupled with robust characterization workflows to support preclinical, toxicology, and pilot-scale manufacturing.
• Collaborate with analytical teams to develop and validate methods for LNP characterization (e.g., DLS, encapsulation efficiency, TEM, HPLC).
• Develop and maintain SOPs and batch records to ensure reproducibility, compliance, and readiness for GMP environments.
• Maintain accurate records using LIMS/ELN systems to support data integrity and reproducibility.
• Prepare technical reports, presentations, and documentation to support internal decision-making and external regulatory submissions.
• Lead tech transfer activities to external CDMOs, including preparation of documentation, training, and troubleshooting support.
• Support regulatory submissions by generating process development reports and contributing to CMC documentation.

Qualifications & Experience

• MS or Ph.D. degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Material Engineering or a related field.
• Minimum of 4+ (with a Ph.D. degree) or 7+ (with a MS degree) years of experience in LNP formulation and process development in pharmaceutical or biotech settings; Scientist candidates are expected to demonstrate leadership in cross-functional project teams, strategic input into platform development, and mentoring of junior staff.
• Demonstrated hands-on experience in designing and implementing high-throughput, automated workflows for LNP formulation and purification, utilizing scalable technologies (e.g., microfluidics, TFF, sterile filtration) to support rapid screening, process optimization, and multiscale production.
• Experience applying Quality by Design (QbD) principles in LNP process development, including the use of Design of Experiments (DoE), risk assessments (e.g., FMEA), and control strategies to define and optimize critical process parameters (CPPs) and critical quality attributes (CQAs) for scalable and reproducible manufacturing.
• Proven track record of experience in regulatory filing for RNA-based therapeutics, IND-enabling CMC studies, and supporting documentation.
• Experience in lyophilization process development for LNP-based formulations, including optimization of cryoprotectants, cycle design, and stability assessment is highly desirable.
• A track record of tech transfer to CDMOs, including documentation and on-site support is a plus.
• Strong problem-solving skills and ability to work independently and collaboratively in a fast-paced multidisciplinary environment.

Apply Here: Career – Agency for Science, Technology and Research