PositionWe are seeking a Scientist to lead downstream process development for the mRNA Engineering team. In this role, you will design, optimize, and scale purification processes for mRNA drug substance.
This is a hands-on, lab-based role that spans program process development and platform engineering. It is ideal for a scientist who enjoys solving purification challenges and scaling processes in a dynamic, fast-paced environment.
What you'll doAs a member of our team, you will:
Develop downstream purification processes- Design, execute, and analyze process development studies for mRNA purification
- Act as the downstream lead for CMC program teams
- Help design and implement automated downstream workflows for high-throughput purification of research-grade mRNA
- Support execution of research-grade mRNA production runs for discovery and preclinical studies, as needed
- Support process scale-up from bench to pilot scale, as needed
- Evaluate emerging purification technologies and chromatography resins
Support tech transfer and CDMO manufacturing- Perform tech transfer of downstream processes to CDMOs
- Act as person in plant during CDMO manufacturing runs
- Support process troubleshooting and deviation investigations at CDMOs
Documentation and collaboration- Maintain organized experimental records in Electronic Lab Notebooks
- Author development SOPs and technical development reports
- Present experiment results at team meetings
Requirements- Ph.D. in analytical chemistry, biochemistry, molecular biology, chemical engineering, or a related field with 0-3 years of relevant industry experience, or an M.S. with 5+ years or B.S. with 7+ years of relevant industry experience
- Hands-on experience developing downstream purification processes for nucleic acids or other biologics
- Hands-on experience with tangential flow filtration (TFF)
- Experience operating C4KTA chromatography systems
- Ability to independently design, execute, and troubleshoot experiments
- Ability to analyze and present complex data sets
- Strong technical writing skills
- Excellent communication and organizational skills
Nice to have- Experience with traditional nucleic acid purification methods (e.g., desalting, precipitation, size-exclusion)
- Experience with plasmid DNA purification
- Experience with Design of Experiments (DoE) and statistical data analysis
- Experience implementing automated or high-throughput purification workflows
- Experience with process transfer to CDMOs
- General understanding of cGMP and phase-appropriate process development
- Familiarity with mRNA analytics such as HPLC, CGE, and dsRNA ELISA
BenefitsNewLimit offers generous benefits to ensure our team can focus on our mission:
- Health, dental, and vision insurance
- 401(k) with company match
- Paid parental leave
- Industry-leading paid time off (PTO) - 20 days/year for all employees + holidays
- Meals and snacks on-site
Salary Range: $120,000-155,000*. Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. NewLimit offers a competitive benefits package, which includes a 401k, healthcare coverage, and 20 days of PTO. Learn more at: https://www.newlimit.com/careers
*This compensation and benefits information is based on Company's good faith estimate as of the date of publication and may be modified in the future.
