Principal/Senior Scientist, mRNA Process Sciences at NewLimit in South San Francisco

Job description

• NewLimit is seeking a Principal/Senior Scientist to drive our mRNA process development and engineering efforts. As our mRNA Drug Substance Lead, you'll own mRNA process development from research-scale production through external GMP manufacturing. This is a hands-on, partially lab-based role requiring deep expertise in optimizing IVT and purification workflows. You'll be reporting directly to our Sr Director of Tech Ops and building out the mRNA Process Sciences team as our pipeline grows.

Responsibilities

• Establish and lead the mRNA process development capabilities at NewLimit, focused on optimizing IVT yield and downstream purification recovery for our preclinical programs.
• Manage the tech transfer and scale up activities at external CDMOs for GLP and GMP mRNA production.
• Partner with our analytical team to formalize internal drug substance analytical methods.
• Lead the mRNA platform production team, establishing a workflow for supplying research-grade mRNA for in vivo and in vitro studies.
• Stay current on emerging mRNA design and manufacturing techniques, proactively bringing new approaches to NewLimit.
• Build the mRNA Process Sciences team within Technical Operations.

Requirements

• PhD in molecular biology, biochemistry, cell biology, or a related field, or equivalent industry experience (5+ years).
• Hands-on experience optimizing IVT reactions and familiarity with the specific challenges of scaling mRNA production (>10 mL scale).
• Hands-on experience optimizing column chromatography purification steps (i.e., oligo-dT) on AKTA systems.
• Proficient in designing and executing UFDF/TFF steps.
• Experience managing external CDMOs, through process development and GMP manufacturing.
• Ability to perform and interpret basic mRNA analytical assays (Fragment Analyzer/TapeStation, restriction-digest + AGE, IP-RP-HPLC).
• Strong analytical skills and demonstrated ability to structure and interpret quantitative process data to guide decisions.
• Strong written communication skills and experience writing detailed technical reports and standardized protocols.
• SME-level understanding of mRNA sequence design and manufacturability assessments.
• Experience with complex plasmid design, bacterial fermentation scale-up, and downstream purification for DNA template generation.
• Experience authoring regulatory submissions (IMPD-Q).
• Experience managing or mentoring RAs/scientists, with interest in growing into a people-management role over time.

Skills

Required

• Experience managing external CDMOs
• Strong analytical skills
• Strong written communication skills

Preferred

• Experience with complex plasmid design

Benefits

• NewLimit 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: $170,000 to $200,000. 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.