Senior Research Associate, LNP Formulation Development

Signify Bio; Dallas (TX); On-site; USD 70,000 - 110,000; Full time

Job summary

Signify Bio seeks a proactive Senior Research Associate for the Formulation and Process Development team. You will handle full-spectrum formulation manufacturing from screening to scalable batches, supporting lipid nanoparticle formulations encapsulating mRNA payloads.

Work closely with process development and analytical teams to optimize CPPs, perform downstream purification, and document experiments in ELN for early-stage research through candidate nomination.

Qualifications

• MS or BS with relevant hands-on lab experience in lipid nanoparticle formulation or drug delivery.
• Experience formulating LNPs or liposomes for screening or process development.
• Proficiency with particle characterization and nucleic acid quantification techniques.

Responsibilities

• Execute rapid screening-scale LNP preparations from sub-mL to low-mL volumes.
• Prepare LNP formulations across research and process development scales.
• Prepare lipid and aqueous phases according to targeted molar ratios.
• Transition research leads into scalable process development batches.
• Evaluate CPPs including flow rates, mixing shear, and diafiltration volumes.
• Perform downstream purification and buffer exchange of LNP formulations.
• Conduct in-process analytics (DLS, zeta potential, RiboGreen).
• Draft SOPs and document batch records in ELN.

Skills

LNP formulation

Microfluidics

TFF/UF-DF systems

DLS (particle size)

RiboGreen assay

NTA

Analytical data tracking

Documentation in ELN

Education

MS in Chemical/Biomedical/Biochemical Engineering or related with 3-5 years lab experience

BS with 5-7 years drug delivery/LNP formulation experience

Tools

Tangential Flow Filtration

Impending jet mixing

Crossflow impinging jet mixing

Hollow-fiber systems

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 proactive and detail-oriented Senior Research Associate to join our Formulation and Process Development team. In this hands-on laboratory role, you will be directly responsible for the full spectrum of formulation manufacturing -- ranging from small research-scale screening formulations to larger process development batches. You will also directly support process development initiatives for lipid nanoparticle (LNP) formulations encapsulating mRNA payloads. Working closely with process development scientists and analytical teams, you will play a key role in executing screening studies, optimizing process parameters, and developing scalable mixing and purification workflows to support early-stage research through candidate nomination.

• Execute rapid, small/screening-scale LNP preparations (sub-milliliter to low-milliliter volumes) to evaluate novel lipid compositions, N/P ratios, and mRNA constructs.
• Prepare LNP formulations across research and process development scales using T-junctions or crossflow impinging jet mixing systems.
• Accurately prepare lipid organic phases (ionizable lipids, helper lipids, cholesterol, PEG-lipids) and aqueous nucleic acid phases according to targeted molar ratios and concentrations.
• Assist in transitioning research-scale leads into robust, scalable process development batches (multi-milliliter to liter scales).
• Help evaluate, systematically test, and optimize critical process parameters (CPPs) - including total flow rates, flow rate ratios, mixing shear rates, concentration factors, and diafiltration volumes.
• Perform downstream purification, concentration, and buffer exchange of LNP formulations using micro-TFF, cassette-based TFF systems, or hollow-fiber systems.
• Perform rapid in-process analytics including dynamic light scattering (DLS) for particle size and polydispersity (PDI), zeta potential, and fluorometric assays (RiboGreen) for mRNA encapsulation efficiency and concentration.
• Draft standard operating procedures (SOPs) and document all experimental details and batch records in an Electronic Lab Notebook (ELN).

Qualifications - Education

• M.S. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, or a related discipline with 3-5 years of relevant laboratory experience; OR
• B.S. with 5-7 years of hands-on experience in drug delivery, liposomes, or lipid nanoparticle formulation.

Qualifications - Work Experience & Skills

• Hands-on experience formulating LNPs or liposomes for screening or process development using microfluidics or impinging jet/T-junction mixing platforms.
• Practical experience operating Tangential Flow Filtration (TFF/UF-DF) systems and benchtop fluid manipulation platforms.
• Proficiency in basic particle characterization techniques (DLS, NTA) and nucleic acid quantification methods (RiboGreen, UV-Vis).
• High degree of self-motivation, strong organization, and meticulous attention to detail in tracking process parameters and batch metrics.
• Adaptable team player capable of prioritizing screening runs while troubleshooting fluidic hardware in a fast-paced environment.
• Clear written and oral communication skills for cross-functional data sharing.

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