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Sr/Principal Engineer

2 months ago

Redwood City, United States Earli Full time

The Position

Earli is seeking a highly motivated, creative, and scientifically rigorous Senior Process Engineer / Principal Process Engineer for DNA/LNP Process Development within CMC. The successful candidate will lead process development and scale-up aimed at improving the quality, yield, and stability of Earli’s DNA/LNP drug products. The position may manage a Research Associate and reports to the VP of CMC at Earli.

Your Primary Responsibilities

  • Design and execute studies for process development of DNA/LNPs in a laboratory setting, including LNP mixing (e.g. microfluidic mixing and T-mixing), TFF and chromatography operations.
  • Optimize LNP mixing and downstream processing unit operations, such as tangential flow filtration (TFF) towards establishing robust and scalable process(es) with phase appropriate control strategies.
  • Design and execute laboratory studies on developing formulation(s) using Design of Experiment (DOE) principles with goal of optimal LNP formulations integrated into LNP process(es) stabilizing the LNP for long-term storage.
  • Routinely collaborate with Platform group to evaluate and characterize LNP physico-chemical properties in various formulations.
  • Conduct drug product studies such as stability, clinical in-use, hold-time, shipping, and freeze/thaw studies for quality using typical analytical techniques (e.g. CE, HPLC, DLS, zeta-potential, and PicoGreen).
  • Play a key role in designing equipment at different scales (phase appropriate) that facilitate high quality CTM manufactured at CDMO/CMO.
  • Provide technical recommendations for evaluating process data, troubleshooting and root cause analysis as well as providing strategic recommendations leading to improved yields, quality attributes, cost of goods and process robustness.
  • Lead/assist in technology transfers, manufacturing operations of DS & DP (e.g. batch record review, change control management, deviation investigation, etc), continuous process improvement including PIP at CDMO/CMO for engineering and cGMP manufacturing campaigns.
  • Document protocols, materials, and results and maintain an extremely thorough laboratory notebook and communicate findings internally to team via presentations and written reports.
  • Support in creating SOPs and Batch records for new and existing processes.

Your Required Experience, Knowledge and Skill

  • Bachelor’s degree in Pharmaceutical Science, Bio/Chemical Engineering, or related fields with 10-12 years of relevant industry experience; or
  • Master’s degree in Pharmaceutical Science, Bio/Chemical Engineering, or related fields with 8 - 10 years of relevant industry experience; or
  • PhD degree in Pharmaceutical Science, Bio/Chemical Engineering, or related fields with 4 - 6 years of relevant industry experience; or
  • Previous hands-on experience with macro-molecule process development, scale-up and technology transfer.
  • Experience with plasmid and lipid nanoparticle process development, formulations, chromatography, TFF skids, and scale-up is preferred.
  • Deep expertise and hands-on experience in formulation and biophysical characterization of lipid-based gene delivery systems is desired.
  • Hands on experience with DLS, CE, Fluorescence, and HPLC is desired.
  • Knowledge of cGMP practices as applicable to technology transfer, manufacturing, drug substance, drug product and analytics is preferred.

Additional Qualifications

  • Strong time management skills, interpersonal skills, adapt to new work plans as needed while ensuring maximum efficiency.
  • Experience managing/mentoring junior team members (Research Associates and Engineers) performing formulation and process development workflows.
  • Able to work effectively in a fast-paced environment with cross-functional teams and external partners.
  • Excellent presentation and written/verbal communication skills.

The base salary for this position is $140k-$180k per year.

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