mRNA-LNP Process Development Scientist

 mRNA-LNP Process Development Scientist

About Kernal Biologics, Inc. 

Kernal Bio is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted LNP technology. By developing in vivo CAR-T therapies, Kernal Bio is advancing precision treatments for autoimmune diseases and blood cancers. The company was founded by experts from MIT, Harvard, Merck, and BMS, and its leadership team brings a track record of three FDA-approved therapies and over 120 patents. Based in Boston, the company is backed by Hummingbird Ventures, Amgen, Lilly, HBM, ARPA-H, and NVIDIA. Kernal Bio is transforming the future of cell therapy design and delivery.

Job Summary:

Kernal Bio seeks motivated mRNA-LNP Process Development Scientists to advance its mRNA 2.0 therapeutic platform. Responsibilities include developing and manufacturing mRNA-LNP therapeutics, conducting analytical characterization, and performing in vitro and in vivo preclinical testing. Candidates must have expertise in mRNA chemistry, biology workflows, and wet-lab methods.

Responsibilities:

• Development, optimization, and troubleshooting of LNP/mRNA manufacturing processes at various scales.
• Characterize LNP formulations and components using Dynamic Light Scattering, Ribogreen, HPLC, etc.
• Develop new assays or detailed investigations of specific LNP attributes as required.
• Screen final formulation buffers and excipients to improve the long-term stability of LNPs

• Manufacture routine mRNA products for preclinical studies
• Optimize and scale up  mRNA-LNP manufacturing capability 
• Develop scalable strategies for downstream product purification 
• Carry out process development studies using the design-of-experiments approach.
• Perform routine analytical and bioanalytical tasks such as HPLC, qPCR, ELISA, fragment analysis, mammalian cell culture, transfection, fluorescence, and flow cytometry
• Help with in vivo studies in rodents for quality validation 

• Maintain up-to-date records and prepare internal reports.
• Analyze, summarize, and present experimental results to team members and management.
• Maintain stocks and supplies for the operation of the Process Development Functions.
• Participate in technology transfer activities related to manufacturing processes and/or analytical methods to external partner programs.
• Contribute to technical discussions & intellectual property related to the development and application of Kernal’s proprietary technologies

Requirements:

• BS/MS and PhD in Chemical Engineering, Bioengineering, Biomedical Engineering, Chemistry, Biology, Molecular Biology, or a similar field
• 2-5 years of academic and industry experience in process development in the context of mRNA, lipid nanoparticles, polymeric nanoparticles, or similar.
• Experience in manufacturing mRNA IVT reactions and mRNA purification
• Experience in manufacturing LNPs using Microfluidics, T-mixer, or other inline mixers.
• Experience with tangential flow filtration (TFF) and sterile filtration.
• Proficiency with related LNP/mRNA analytical techniques (e.g. plate-based fluorescence assays, HPLC, LC/MS)
• Familiarity with ELN and GraphPad Prism.
• Preferred: Experience with bioprocess engineering principles, process modeling, and Design of Experiment (DoE) statistical tools.
• Preferred: Experience with tech transfer to GMP manufacturing.
• Attention to detail, ability to multi-task, and complete deliverables within timelines.
• Strong written and verbal communication skills.
• Adaptability and enthusiasm for new challenges and a passion for learning in a fast-paced startup setting.
• Ability to work independently while effectively interacting and collaborating in a team environment.

Benefits:

• Competitive 401(k)   
• Highly competitive healthcare coverage (PPO/HMO)
• Free parking, monthly subway pass, or a subsidized commuter rail pass  
• Free Bluebike Membership
• Gym Membership Support   
• Paid parental leave, family caregiver leave, medical leave  
• Paid life insurance coverage 
• On-site cafeteria  
• Competitive vacation and sick days per year 

Kernal provides a diverse work environment and is committed to equal employment opportunities for all its employees and qualified applicants. We do not discriminate in employment practices based on race, color, national origin, age, gender, sexual orientation, marital or veteran status, religion, disability, or any other legally protected status. Kernal Bio will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.