Process Development Scientist

1 week ago

Brisbane, Queensland, Australia beBeeLnp Full time

Scientist Role Summary

Seeking a seasoned professional to spearhead process development and optimization in LNP-based delivery systems. The ideal candidate will have hands-on experience with microfluidic and high-shear mixing technologies, tangential flow filtration, and dead-end filtration.


Key Responsibilities:

  • Process Development and Optimization: Apply Quality by Design (QbD) principles to design and execute experiments for identifying and controlling critical process parameters (CPPs).
  • Analytical Characterization: Develop and optimize analytical methods using techniques such as DLS, Ribogreen, HPLC-CAD, IP-RP-HPLC, and endotoxin analysis to identify and assess critical quality attributes (CQAs).
  • Data Interpretation and Analysis: Assess process robustness and guide iterative development efforts based on data interpretation.
  • Collaboration and Communication: Support cross-functional teams and effectively communicate scientific findings and project updates.
  • Technology Transfer: Prepare comprehensive technical documentation for successful external manufacturing transfer.
  • Staying Current: Stay up-to-date with emerging trends in LNP technologies to contribute to strategic process improvements.

Required Qualifications:

  • Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, Chemistry, or related field with minimum 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.
  • Proficiency in analytical characterization techniques for LNPs, including DLS, fluorescence-based assays, and HPLC/UPLC methods.
  • 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.
  • Demonstrated strong organizational skills.
  • A self-starter with strong troubleshooting skills, capable of driving projects independently while contributing effectively in a collaborative environment.

Preferred 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 interest in viral delivery systems.

Compensation and Benefits:

  • A competitive base salary range of $157,000 - $178,000 per year.

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