Senior Scientist, LNP Process Development
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
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.
- 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!