Job Description

Your Responsibility:  

• Develop qualifiable analytical methods for LNP products
• Support assay verification and qualification
• Lead technology transfer to internal and external QC departments. Provide technical support for deviation investigations, test method optimization
• Support process development teams for in-process testing and process understanding.
• Partner with internal and external stakeholders in establishing product characterization package and release specifications.
• Draft, revise, and review relevant technical documents, including but not limited to SOPs, analytical methods, development reports, qualification reports, method transfer plans, and transfer reports.
• Accurately and promptly record scientific data, maintaining detailed experimental records in compliance with applicable quality standards, safety, and environmental requirements.
• Qualify, calibrate, and maintain laboratory instruments and equipment. 

Must-have Qualifications:  

• Master’s degree or higher in Biochemistry, Molecular Biology, Cell Biology, Immunology, Oncology, Synthetic Biology, or a related field, with at least 3 years of relevant work experience. Experience in pharmaceutical and biotechnology companies is preferred.
• Proficient in LNP characterization such as DLS, zeta potential, RNA and protein quantification, HPLC, Flow Cytometry, and data analysis software 
• Familiar with cGMP requirements, and experienced in assay development within relevant fields
• Ability to analyze experimental data, summarize and report results, and provide feasible solutions to challenges encountered in projects. Responsible for writing technical documents.
• Regulatory knowledge related to LNP products
• Strong verbal and written communication skills 

Desirable Qualifications:  

• Experience with LNP GxP manufacturing and QC 
• Experience with Mab and/or ADC analytical development 
• Experience with mRNA analytical methods 

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