Advanced Gene Therapy Production Expert

1 week ago

Brisbane, Queensland, Australia beBeeLnpDevelopment Full time $138,000 - $178,000
Job Title: LNP Process Development Specialist

We are seeking a highly skilled and experienced professional to join our team as an LNP Process Development Specialist.

This role is critical for developing, optimizing, scaling, and characterizing LNP-based delivery production processes for cutting-edge gene editing platforms.

The ideal candidate will thrive at the interface of process development, analytics, and manufacturing—someone who can transition smoothly between the bench and discussions with external partners.

Key Responsibilities:
  • Process Development: Design and optimize LNP manufacturing processes by applying Quality by Design (QbD) principles and execute Design of Experiments (DoEs) to identify and control critical process parameters (CPPs)
  • Analytical Method Optimization: Optimize analytical methods such as DLS, Ribogreen, HPLC-CAD, IP-RP-HPLC, and endotoxin to identify and access critical quality attributes (CQAs)
  • Data Interpretation: Interpret analytical data to assess process robustness and guide iterative development efforts
  • Collaboration: Collaborate with internal teams to support process improvements and drive innovation
  • Communication: Clearly present scientific findings and project updates in internal meetings and to external collaborators
  • Technology Transfer: Drive technology transfer activities with external CDMO partners by preparing comprehensive technical documentation such as development reports, process summaries, and tech transfer packages to ensure successful external manufacturing
  • Staying Current: Stay current with emerging trends in LNP technologies and contribute to strategic process improvements
  • Laboratory Management: Track inventory, plan experiments, and contribute to an organized, quality-focused lab environment
Requirements:
  • Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, Chemistry, or a related field with minimum of 3 years relevant industry experience; or M.S. with 6 years; or B.S. with 8 years
  • Demonstrated expertise in LNP formulation and process development, including hands-on experience with microfluidic and high-shear mixing technologies, tangential flow filtration and dead-end filtration
  • Proficiency in analytical characterization techniques for LNPs, including DLS, fluorescence-based assays and HPLC/UPLC methods (CAD, UV, IP-RP, SEC, IEX), including method development, troubleshooting, and data interpretation
  • Experience with in-process and drug product stability studies
  • Proven success in applying DoEs and statistical analysis tools for process optimization
  • Experience supporting technology transfer of processes to external manufacturing environments, with a strong understanding of tech transfer best practices
  • Demonstrated strong organizational skills
  • A self-starter with demonstrated strong troubleshooting skills, capable of driving projects independently while contributing effectively in a collaborative, multidisciplinary environment
Desirable Qualifications:
  • Knowledge of regulatory expectations for CMC development
  • Familiarity with high-throughput screening methods
  • Exposure to cell-based assays for LNP functional characterization
  • Familiarity with data analysis tools and statistical methods such as JMP
  • Experience with AAV vector process development or a strong interest and adaptability to learn viral delivery systems

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