People Matter

Senior Scientist, LNP Process Development



Redwood City, CA, USA
Posted on Wednesday, January 3, 2024

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 Process Development and Manufacturing in the Delivery team.

Your Primary Responsibilities

You will use your expertise in Lipid Nanoparticle (LNP) scale-up and process development to establish robust processes and assays for producing high-quality Research-Grade LNP batches of an existing proprietary LNP formulation at 50 milligram to >1 gram scale for animal studies.

You will:

  • Develop large scale upstream (mixing) and downstream (tangential flow filtration) operations for producing high-quality Research-Grade LNP batches for small and large animal efficacy and toxicity studies. Minimum scale is 50 milligram, scaling up to >1 gram using external partners.
  • Develop and qualify robust analytical methods to measure LNP size, polydispersity, encapsulation efficiency, lipid composition, API integrity, and potency; and write SOPs to characterize LNP batches and issue CoAs
  • 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
  • Work with CROs/CMOs to transfer knowhow, analytical methods, and process operations to support GMP manufacturing. Serve as a scientific liaison and subject-matter expert in tech transfer discussions
  • Routinely produce LNP batches across multiple scales using formulation platforms such as microfluidic mixing, Impingement Jet Mixing, etc. for animal studies
  • Be an integral member of the Delivery team and contribute to novel delivery formulation development, screening of ionizable and helper lipids, and pre-clinical evaluation
  • 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, process development, and scale-up is a must. Experience with manufacturing nucleic acid formulations (siRNA, mRNA or DNA) at scale > 50 mg is a pre-requisite for this role. Experience scaling up to 5 gram or more is not required but highly desirable
  • Expertise in Tangential Flow Filtration method development for buffer exchange and concentration is a pre-requisite for this position
  • Expertise in analytical method development for LNP size, polydispersity (light scattering), encapsulation efficiency (fluorescent plate-based assays), lipid composition, API integrity (HPLC expertise preferred), and potency, etc.
  • Experience with multiple formulation platforms (microfluidics, T-mixer, etc.)
  • Experience with a broad range of molecular and cell-based assays for evaluating delivery formulation performance
  • Knowledge of and first-hand experience with tech transfer to GMP manufacturing, CMC requirements for regulatory filings is a plus, and is preferred
  • Experience with high-throughput screening methods such as DoE for optimizing manufacturing processes 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!