Lnp Process Development Specialist

1 week ago

Brisbane, Queensland, Australia beBeeGeneEditing Full time $138,000 - $178,000

Gene Editing Delivery Specialist

Mammoth Biosciences is seeking a highly skilled individual to join its CMC team in a hands-on, cross-functional role that blends scientific ingenuity with operational excellence.
This position is critical for developing, optimizing, scaling, and characterizing LNP-based delivery production processes for 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.
This is a great opportunity to play a key role in advancing transformative gene editing therapies into the clinic and beyond.

Key Responsibilities:

  • Apply Quality by Design (QbD) principles to design and optimize LNP manufacturing processes, execute Design of Experiments (DoEs), and identify and control critical process parameters (CPPs)
  • Optimize analytical methods such as DLS, Ribogreen, HPLC-CAD, IP-RP-HPLC, and endotoxin to identify and assess critical quality attributes (CQAs)
  • Interpret analytical data to assess process robustness and guide iterative development efforts
  • Collaborate with internal teams to support process improvements and drive innovation
  • Present scientific findings and project updates effectively in internal meetings and to external collaborators
  • 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
  • Stay current with emerging trends in LNP technologies and contribute to strategic process improvements
  • Manage inventory, plan experiments, and contribute to an organized, quality-focused lab environment

Essential Skills and Qualifications:

  • Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, Chemistry, or a 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, 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
  • Strong organizational skills
  • A self-starter with demonstrated strong troubleshooting skills, capable of driving projects independently while contributing effectively in a collaborative, multidisciplinary environment

Additional Requirements:

  • 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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