Scientist, mRNA Analytical Development

NewLimit; South San Francisco (CA); On-site; USD 120,000 - 155,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) with company match

Paid parental leave

Industry-leading PTO 20 days/year +hol

Meals and snacks on-site

Job summary

NewLimit is seeking a Scientist in South San Francisco to establish and grow its mRNA analytical testing suite. You will build analytical methods for DNA templates and mRNA drug substances, driving process development toward the clinic.

This hands-on role interfaces with Delivery Sciences, research teams, and external CDMOs, ideal for an analytical scientist who enjoys building from the ground up and expanding scope.

Qualifications

• PhD or MS/BS with substantial industry experience in analytical methods for DNA/mRNA products.
• Experience developing and qualifying mRNA analytical methods.
• Hands-on execution and troubleshooting of analytical assays.

Responsibilities

• Build the analytical suite for DNA templates and mRNA drug substance release/characterization.
• Run routine testing to support process development and research programs.
• Lead method development studies: robustness, specificity, sensitivity, precision, accuracy, linearity.
• Author protocols and reports; transfer methods to CDMOs; present results.

Skills

Analytical chemistry

Biochemistry

Molecular biology

Data analysis

HPLC

Capillary electrophoresis

qPCR

ELISA

Scientific writing

Communication

Organizational skills

Education

PhD in analytical chemistry, biochemistry, molecular biology, chemical engineering, or related field

MS with 5+ years of industry experience

BS with 7+ years of industry experience

Tools

HPLC (IP-RP-HPLC)

SEC

Capillary electrophoresis

qPCR

ELISA

LC-MS

Job description

NewLimit is a biotechnology company working to radically extend human healthspan. We're developing medicines to treat age-related diseases by reprogramming the epigenome, a new therapeutic mechanism to restore regenerative potential in aged and diseased cells. We leverage functional genomics, pooled perturbation screening, and machine learning models to unravel the biology of epigenetic aging and disease using experiments of unprecedented scale.

Position

We are seeking a Scientist to establish and grow NewLimit's mRNA analytical testing suite. In this role, you will lead the development of analytical methods to characterize our DNA templates and mRNAs. The assays you build will drive mRNA process development efforts as our programs advance toward the clinic.

This is a hands-on, lab-based role within Technical Operations that will interface with Delivery Sciences, research teams, and external CDMOs. It is ideal for an analytical scientist who enjoys building from the ground up and wants to expand their scope.

What you'll do

As a member of our team, you will:

Build the analytical suite

• Develop and establish analytical methods for DNA template and mRNA drug substance release and characterization
• Lead studies to evaluate method robustness, specificity, sensitivity, precision, accuracy, and linearity, and set phase-appropriate performance criteria
• Act as the mRNA analytical lead for CMC program teams
• Evaluate emerging analytical technologies to expand our internal testing capabilities

Run and maintain the assays

• Perform routine testing of DNA templates and mRNA materials to support process development and research programs
• Investigate unexpected impurities, degradation, and atypical results
• Maintain instruments, reference standards, assay controls, and critical reagents

Documentation and collaboration

• Author method protocols and technical development reports
• Support method transfer and qualification at CDMOs
• Present experiment results at team meetings
• Manage the outsourcing of advanced analytical techniques to CROs, as needed

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
• Experience with assay development and qualification across a broad range of mRNA analytical methods
• Hands-on experience executing and troubleshooting HPLC separations (e.g., IP-RP-HPLC, SEC), capillary electrophoresis, and plate based assays for impurity quantification (e.g. qPCR, ELISA)
• 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

• Understanding of the analytical method lifecycle and phase-appropriate method qualification
• Experience with sequencing workflows and data analysis, including Sanger and Oxford Nanopore Technologies
• Experience with LC-MS assays for evaluating poly(A) tail length and capping efficiency
• Experience transferring analytical methods to CDMOs

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: $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.