Research Associate I/II/Sr. RA, LNP Analytical Development and Operation

Company description

We are a privately held, stealth mode start-up biotechnology company developing lipid nanoparticle-based approaches to address unmet medical needs.

The role

We are looking for a highly motivated Research Associate I/II or Senior, Scientist I/II, Senior Scientist, Principal Scientist – LNP Analytical Development and Operation to join an experienced, fast-paced and collaborative team, who is responsible for analytical method development and/or routine testing for LNP platform to support programs from discovery through IND-enabling studies.

Roles and Responsibilities of the position:

• Development, optimization, and qualification of novel analytical methods to characterize LNP/tLNP components and product, including DLS, HPLC, LC-MS, CE, iCIEF, DLS, ELISA, and plate-based assays.

• Phase-appropriate buildout of analytical methods for extended characterization, product release, stability, comparability, and compatibility.

• Conduct and/or manage internal routine, non-routine, and stability testing of lipid, mRNA, antibody, antibody conjugates, LNP and targeted LNP drug products

• Support method transfer and troubleshooting with external CROs/CDMOs

• Analytical investigations into deviations and OOS results

• Draft technical reports and analytical sections for regulatory filings

• Working closely with the technology development and research teams, this position will drive process/product understanding, support expansion of the LNP platform, lead product investigations, and guide phase-appropriate development and refinement of QC and extended characterization methods.

Required Qualifications:

• Scientist level, PhD with 1+ year relevant experience; OR M.S. with 3+ years; OR B.S. with 5+ years or above. Level will be determined based on experience.

• Research associate level, M.S. with 1+ years relevant experience; OR B.S. with 1+ years. Level will be determined based on experience.

• Degree in Biochemistry, Chemistry, Bioengineering, Chemical Engineering, Pharmaceutical Sciences, or related field with proven technical and leadership track record developing analytical methods for Biologics (LNPs, tLNPs, mRNA, antibodies, etc) is required

• Technical expertise for applying current analytical methodologies for lipid excipients, antibodies, mRNA, LNP and targeted LNP therapeutics

• Demonstrated operational excellence in routine and ad-hoc testing

• Experience with designing and executing stability, comparability, and compatibility studies to ensure product integrity and efficacy

•Direct experience analyzing LNPs and RNA by biophysical techniques such as LC-MS, DSC, DLS, MALS, etc.

•Demonstrated competency in operating HPLC/UPLC/LC-MS instrumentation.

•Hands-on experience analyzing DNA/RNA by IP-RP, IEX, LC-fluor and multi-modal LC techniques required.

• Exceptional communication skills, both written and verbal, with a demonstrated capacity to thrive in collaborative, team-driven environments.

Additional Preferences:

• Experience with analytical control strategy implementation and phase-appropriate analytical development, as well as international regulatory submissions related to advanced gene therapies or other similar application

• Experience with method transfer, qualification, and validation with CROs/CDMOs is strongly preferred

• CAR-T, in vivo CAR-T drug product analytical development, or LNP related drug product analytical development, or gene editing analytical drug product development experience preferred

• Ability to anticipate challenges and propose proactive solutions.

What We Offer

• Opportunity to work at the forefront of innovation

• Collaborative, science-driven culture with high impact research

• Competitive compensation and benefits package, including health, dental, vision, and life insurance

• 401(k) with company match