Senior Scientist, LNP Formulation and Process Development

About Earli 

The mission of the Biotechnology startup Earli Inc. is large and ambitious: to detect and then cure cancer at its earliest stages, effortlessly and pain free. In other words, ‘make cancer a benign experience’. The technology which grounds the company’s efforts ushers in a new era in “synthetic biomarkers” as a novel methodology to detect cancer and then subsequently localize and then treat the cancer.  The enabling technology utilizes “synthetic biomarkers” as a novel methodology to detect, localize and ultimately destroy cancer.   Founded by Sam Gambhir, Cyriac Roeding and David Suhy, the company is well funded by world-class entrepreneurs and venture capital firms. Earli, Inc. is currently based in Redwood City, California. 

Who You Are

• You share our same sense of dedication, scientific passion and entrepreneurial spirit 
• You work well in a fast-paced and extremely focused startup environment 
• You are not only smart, but clever and constantly think outside the box 
• You are able to make logical decisions in an instant when there is little time to evaluate 
• You are a natural communicator and relationship builder 
• You stay calm under high pressure and stress 
• You have the ability to multi-task in a serious way, with an extreme attention to detail 
• You become a representative of the core DNA of the company through who you are 

The Position

Earli Inc. is seeking a high-caliber Senior Scientist for LNP Formulation and Process Development in the Delivery team.

Your Primary Responsibilities

You will use your expertise in lipid nanoparticle formulation development to establish robust processes and assays for producing LNPs at multiple scales from early screening to large animal studies.

You will:

• Routinely formulate and characterize LNPs at small scale using multiple formulation platforms for Earli’s screening pipeline
• Evaluate LNP formulations using cell-based assays and collaborate with translational biology team to test in vivo
• Optimize LNP formulations by medium to high-throughput screening of ionizable and helper lipids and other additives to enhance potency without concomitant toxicity
• Develop large scale formulation and downstream process development operations for producing high-quality LNP materials for large animal efficacy and toxicity studies
• Develop final formulation buffers and excipients to establish long-term stability of LNPs – colloidal as well as functional stability of API - to meet target clinical dosage form requirements
• Develop robust analytical methods and SOPs in collaboration with other teams and CROs as needed to support LNP process development and tech transfer to GMP manufacturing
• Be an integral member of the Delivery team and contribute to novel delivery formulation development, testing, and clinical translation
• Document protocols, materials, and results and maintain an extremely thorough electronic laboratory notebook
• Communicate findings internally to team via presentations and written reports.

Your Required Experience, Knowledge and Skills

• PhD degree in Chemical Engineering, Bioengineering, or other engineering discipline, with a minimum of 4-6 years biotech industry experience
• Deep expertise in lipid nanoparticle formulation. Experience with LNP process development and scale-up is a must
• Experience with multiple formulation platforms (microfluidics, T-mixer, etc.)
• Experience with downstream process development operations like Tangential Flow Filtration for buffer exchange and concentration, sterile filtration, etc. is a must
• Experience with analytical method development for LNP size, concentration, encapsulation efficiency, potency assays, HPLC assays for lipid composition analysis, etc.
• Experience with a broad range of molecular and cell-based assays for evaluating delivery formulation performance
• Knowledge of and first hand experience tech transfer to GMP manufacturing, CMC requirements for regulatory filings is a plus
• Experience with high-throughput screening methods such as DoE for optimizing LNP formulations is a plus
• Excellent verbal communication and interpersonal skills
• Ability to lead projects independently, multi-task effectively, and integrate fully into a high achieving team environment

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!