Company Description
We are a privately held, stealth-mode start-up biotechnology company developing lipid nanoparticle–based approaches to address unmet medical needs.
The Role
We are seeking a motivated, hands-on Senior Associate Scientist to join our mRNA drug substance (DS) process development team. In this role, you will run and optimize mRNA synthesis, from DNA template through in vitro transcription (IVT), filtration, and purification, and help produce mRNA in-house to supply discovery and IND-enabling studies. This is a lab-based role for someone who enjoys being at the bench, is eager to learn, and wants to grow with a small, fast-moving team.
Roles and Responsibilities
mRNA Process Development
- Design and perform hands-on experiments for DNA template linearization, IVT, and downstream purification, including tangential flow filtration (TFF) and chromatography.
- Optimize yield, purity, and recovery, and support scale-up of processes from bench to pilot scale.
- Support process characterization studies (e.g., DoE) with guidance from senior team members.
- Help evaluate new reagents, equipment, and methods that could improve process performance.
Internal Production
- Execute internal mRNA production runs to supply research- and toxicology-grade material for discovery and IND-enabling studies.
- Maintain lab equipment, critical reagents, and inventory to keep production on schedule.
- Keep accurate records in the electronic lab notebook (ELN) and LIMS; draft batch records, SOPs, and technical reports.
Collaboration
- Work with analytical development to characterize mRNA and use the data to guide process decisions.
- Partner with LNP formulation and analytical teams, and support technology transfer to internal GMP manufacturing and CDMOs as needed.
- Present results clearly at team and project meetings.
Required Qualifications
- BS with 4+ years, or MS with 2+ years, of relevant industry laboratory experience in biochemistry, chemical engineering, molecular biology, or a related field.
- Hands-on experience in mRNA process development is a must, including IVT and downstream purification (TFF and/or chromatography).
- Familiarity with common analytics for plasmid and mRNA such as HPLC, UV-Vis, and Bioanalyzer/CGE.
- Strong attention to detail and good documentation practices.
- Genuine passion for mRNA science and a strong willingness to learn new techniques and take on new challenges.
- Good communication and organizational skills; able to thrive in a fast-paced, collaborative team.
Preferred Qualifications
- Exposure to Design of Experiments (DoE) and statistical data analysis.
- General understanding of cGMP and Quality by Design (QbD) principles.
- Experience with plasmid DNA preparation and linearization.
- Experience working in a start-up or small-team environment.
Location
San Diego, CA. This is an on-site position.
What We Offer
- An opportunity to work at the forefront of mRNA and LNP-based therapeutic innovation
- A collaborative, science-first culture where individual contributions are visible and impactful
- Hands-on training and room to grow your technical skills and career
- Competitive compensation and benefits package, including health, dental, vision, and life insurance
- 401(k) with company match