LNP CMC Lead Scientist

As a senior scientist in the LNP process development team, will lead and execute the process development, optimization, scaling-up and technology transfer of specific LNP formulations, ensuring the robustness, repeatability and compliance of the process with the requirements of subsequent GMP production. The candidate is required to have profound theoretical and practical knowledge of LNP, excellent communication and collaboration skills, and a deep understanding of the CMC path.

Responsibilities:

1. Mainly responsible for the development of LNP formulation process, using different DS solutions and target indications, designing and optimizing the formulation and preparation process of LNP.

2. Independently plan and execute experiments, systematically optimize key process parameters to achieve high encapsulation rate, reasonable particle size distribution, and good stability.

3. Write detailed technical development reports to clearly present data, conclusions and recommended solutions to the superior leaders.

4. Process scaling-up and technology transfer: - Lead the process scaling-up research from laboratory scale to preclinical and early clinical production scale (such as from milliliters to upgrade); - Identify and solve key process problems during scaling-up to ensure the robustness and scalability of the process.

5. Analysis and characterization support: - Work closely with the analytical development team to define LNP key quality attributes and ensure that the process developed during the research can stably produce products meeting the preset CQA; - Be familiar with various characterization tools (DLS, HPLC, fluorescence-based encapsulation rate determination, stability indication analysis methods, etc.) to evaluate the impact of process changes on product quality.

Requirements:

1. Master's degree or above, with experience in LNP or lipidosome nanodelivery systems, and those with experience in active targeting LNP, active targeting nanodelivery systems or ADC processes are preferred.

2. Able to independently design, conduct and complete relevant experiments, organize records and write reports; be able to analyze and effectively solve problems arising in the research; familiar with the process development concept, have the full product development thinking throughout the process.

3. Good reading ability of literature, good report summarization and writing ability.

4. Understand the standardization of CMC research process and execute it, have good research literacy, be familiar with the standard procedures of CMC stage research, ensure the compliance of the research work, strictly follow laboratory standards.

5. Those with project application experience are preferred.