Sr/Principal Engineer - Process Development

at  Earli Inc

ABOUT EARLI

Earli exists to make cancer a benign experience. Earli does that by turning cancers against themselves: genetically forcing them to reveal themselves early, and then kill themselves – precisely and clearly distinguishable from benign lesions at early stages. Based on original technology from Stanford’s renowned Gambhir lab, Earli designs genetic constructs that are injected intravenously that turn cancer cells against themselves. These programmable synthetic promoter-reporter sequences “flip on” like light switches only in dysregulated cancer cells and turn them into “factories.” The cancer is forced to produce either an epitope “docking station” for imaging agents, or a cytokine for immune system activation against the tumor. Thus, Earli’s platform enables immediate diagnosis and treatment of early cancers, rather than long-term observation that can lead to deadly metastatic recurrence.
Earli’s synthetic target expression platform has evolved over five years of deep bioengineering. The system can now detect broad ranges of patient mutations, distinguish between malignant and benign lesions, and offer independence from often elusive natural biomarkers.
Earli has raised $82m in three rounds from investors including Andreessen Horowitz, Khosla Ventures, Emerson Collective, Stanford, Perceptive Advisors, Casdin Capital, Marc Benioff, Sands Capital, Breyer Capital, Tailwinds (American-Korean) etc.
Its Scientific Advisory Board includes Jim Allison (Nobel Laureate, Immuno Oncology), Bob Langer (MIT, co-founder Moderna), Phil Greenberg (Hutch, co-founder Juno), Pam Sharma (MD Anderson), Charlie Rudin (Sloan Kettering), Alan Ashworth (UCSF Cancer Center).

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 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.

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

• 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.

If interested in applying, please attach a CV or have a well-developed LinkedIn profile for us to be able to assess your background.
We look forward to hearing from you

• 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.