Principal Scientist

Signify Bio; Dallas (TX); On-site; USD 180,000 - 240,000; Full time

Job summary

Signify Bio is seeking a Principal Scientist to lead the mRNA and Lipid Nanoparticle Analytical Development team within the CMC organization. You will develop, validate, and implement analytical assays to characterize mRNA drug substance, lipid materials, and LNP drug products for SEND mRNA and iPHOS LNP platforms.

Responsibilities include establishing control strategies, release/stability panels, and supporting regulatory filings while mentoring scientists and collaborating with Formulation,

Qualifications

• Deep expertise in analytical development for mRNA constructs and LNPs.
• Proven experience in chromatography, electrophoresis, and light scattering for LNPs.
• Strong record of mentoring lab researchers and managing projects.
• Understanding of analytical control strategies and stability testing for nucleic acids and nanoparticles.

Responsibilities

• Lead analytical development for mRNA drug substance and LNP products.
• Design and qualify assays including HPLC/UPLC, capillary electrophoresis, and DLS.
• Establish panels for release, stability, and characterization of candidates.
• Mentor analytical scientists and oversee lab operations.
• Coordinate tech transfer to CDMOs/CTOs and support scale-up with CMC teams.
• Communicate complex data to leadership and project teams.

Skills

Analytical development

mRNA constructs

Lipid nanoparticle formulations

Team mentoring

Cross-functional collaboration

Communication skills

Education

PhD or equivalent in Analytical Chemistry / Pharmaceutical Sciences / Biochemistry

M.S. with 12+ years of related biopharma experience

Tools

RP-HPLC / SEC / IEX / CAD/ELSD

Capillary electrophoresis

Dynamic light scattering (DLS)

RiboGreen/encapsulation assays

Job description

Signify Bio is a biotechnology company transforming the development of in situ protein therapeutics by leveraging the human body’s natural ability to produce proteins. Guided by its mission to create personalized medicines for all, Signify combines the precision of signal peptide engineered control with the speed and versatility of mRNA encoded design. The company’s SEND platform and iPhos lipid nanoparticles enable targeted and localized delivery of therapeutic proteins, addressing significant unmet needs across various diseases. Through innovative science, Signify Bio is committed to advancing solutions that make a meaningful difference for patients worldwide.

At Signify, we bring together collaborative teams, innovative science, and a shared commitment to addressing meaningful unmet patient needs. Employees have the opportunity to work across disciplines, contribute to cutting-edge therapeutic programs, and help translate scientific discoveries into potential medicines. We value scientific rigor, open communication, curiosity, and teamwork, and we encourage every team member to contribute ideas, take ownership, and grow alongside the organization.

Position Summary

We seek a highly experienced and innovative Principal Scientist to lead our mRNA and Lipid Nanoparticle (LNP) Analytical Development team within the CMC organization. The successful candidate will be responsible for the development, validation, and implementation of robust, cutting-edge analytical assays to characterize mRNA drug substance, lipid raw materials, and LNP drug product in support of Signify’s proprietary platforms (SEND mRNA and iPHOS LNP). The role works in close collaboration with Formulation, Molecular Biology, Process Development, and Quality to define analytical control strategies, establish stability programs, and support regulatory filings.

Essential Duties and Responsibilities

• Function as Signify’s subject matter expert in analytical methodology for mRNA drug substance and LNP drug product characterization.
• Lead the design, optimization, qualification, and execution of analytical assays including HPLC/UPLC (SEC, RP, IEX, CAD/ELSD), capillary electrophoresis, dynamic light scattering (DLS), RiboGreen/encapsulation assays, and physical-chemical profiling.
• Establish release, stability, and characterization panels for early- and late-stage mRNA/LNP candidates supporting in vivo studies, lead selection, and CMC progression.
• Manage and/or mentor analytical scientists/research associates, overseeing daily laboratory operations, assay execution, and data interpretation.
• Oversee analytical technology transfer to external CDMOs/CTOs and collaborate with internal CMC teams to support scale-up and process characterization.
• Summarize, interpret, and communicate complex scientific data to cross-functional leadership, governance committees, and project teams.

Qualifications – Education

PhD or equivalent advanced degree in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related discipline with 10+ years of relevant industry experience; or M.S. with 12+ years of related biopharma industry experience.

Qualifications – Work Experience & Skills

• Deep expertise in analytical development specifically for mRNA constructs, lipid raw materials, and lipid nanoparticle formulations.
• Proven experience developing and validating chromatography (e.g., RP-HPLC, SEC, IEX with UV/CAD/ELSD), electrophoresis, and light scattering methods for LNP characterization.
• Demonstrated track record of managing, coaching, and mentoring a team of lab-based scientists.
• Strong understanding of phase-appropriate analytical control strategies, assay qualification, and stability testing guidelines for nucleic acid and nanoparticle modalities.
• Ability to efficiently manage and prioritize multiple projects while coordinating in-house research with external collaborative work.
• Excellent oral and written communication skills with a strong ability to collaborate effectively across multidisciplinary teams and leadership.

Physical Requirements

Position requires the physical ability to work in a lab setting and utilize standard lab equipment for extended periods of time. Occasional travel (<10%) may be required, typically domestic.

Signify Bio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.