Senior Scientist I / II, tLNP Formulation
$109,500–$208,500 year
On-site · North Chicago, Illinois, United States
Job Summary
Senior Scientist I/II to lead key scientific initiatives in targeted Lipid Nanoparticle (tLNP) drug product development. Develop risk-based formulation and process development strategies for clinical-stage tLNP programs, represent the tLNP formulation team in cross-functional forums, guide CMC deliverables including IND- and BLA-enabling activities, and inform excipient selection through stress testing. Design and execute formulation screening studies evaluating variables such as pH, buffers, antioxidants, surfactants, cryoprotectants, and other stabilizing excipients; lead process development, optimization, robustness studies, and sterile fill-finish operations. Facilitate scale-up and technology transfer with internal and external stakeholders; apply Design of Experiments to optimize formulations and process parameters; develop clinical in-use strategies and assess in-use stability for clinical programs; plan experiments for advanced formats (lyophilized forms, spray drying, nonaqueous suspensions); interpret and present data and recommendations to internal and cross-functional teams; maintain high lab productivity with strict safety, quality, and good research practices; ensure robust documentation in ELNs and technical reports; together with the team, drive formulation development for AbbVie’s tLNP pipeline.
Required Qualifications
- PhD in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or a related field (0+ years industry experience); or MS with 6+ years of relevant industry experience for senior scientist I
- PhD in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or a related field (4+ years industry experience); or MS with 10+ years of relevant industry experience for senior scientist II
- Comprehensive theoretical knowledge of ICH regulations governing drug product formulation and sterile process development
- Proven experience in formulation, process development, and analytical characterization of protein therapeutics
- Experience characterizing thermal (glass transition, recrystallization) and physico-chemical (pH shifts) events taking place at sub-zero temperatures (typically -20°C to -80°C) in frozen drug product solutions
- Proficient in formulation characterization methods such as Dynamic Light Scattering (DLS), Differential Scanning Calorimetry (DSC), and chromatographic techniques (RP-HPLC, SEC, IEX)
- Demonstrated ability to independently design, execute, and troubleshoot complex formulation experiments
- Skilled at analyzing and interpreting multidisciplinary datasets to enable scientific decision-making
- Exceptional written and verbal scientific communication skills
- Hands-on experience in mRNA, lipid nanoparticles (LNP), targeted LNP systems, or biologics drug product development
- Demonstrated expertise in biologics manufacturing processes, including sterile fill-finish operations, lyophilization, and spray drying
- Strong familiarity with LNP and protein formulation characterization techniques such as mRNA encapsulation efficiency assays and antibody binding assays (qELISA)
- Proficient in utilizing statistical software and Design of Experiments (DoE) methodologies for process and formulation optimization.
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