Job DescriptionAbout the TeamThe Targeted Lipid Nanoparticle (tLNP) drug product development group within AbbVie's tLNP CMC team is committed to advancing clinical-stage tLNP assets from First-in-Human (FIH) through Phase 2. The team collaborates across biologics discovery, CMC partners, Clinical Operations, Regulatory Affairs, Quality Assurance, and external manufacturing to support development and commercialization of tLNP products. Key focus areas include establishing robust formulation and process development capabilities, leading critical CMC activities for pipeline programs, devising formulation development strategies, conducting stability evaluations, optimizing clinical in-use strategies, developing innovative product presentations, implementing stage-based quality risk management, and driving scientific initiatives to ensure the strong development of current and future tLNP programs.
PurposeAbbVie is seeking a highly motivated Scientist I/II to support the development of early-stage targeted Lipid Nanoparticle (tLNP) assets within AbbVie's pipeline. The successful candidate will contribute to formulation and process development activities through hands-on laboratory experimentation, data analysis, and scientific problem solving. This role will work closely with cross-functional teams including analytical sciences, process development, manufacturing, and subject matter experts to advance tLNP drug product development from early research through clinical enablement.
Responsibilities- Design, execute, and interpret formulation and process development experiments to support tLNP drug product development.
- Conduct formulation screening studies evaluating variables such as pH, buffer systems, cryoprotectants, surfactants, antioxidants, and other excipients to improve stability and performance of tLNP formulations.
- Support process development activities including formulation preparation, sterile filtration, freeze-thaw evaluations, lyophilization development, and other drug product unit operations.
- Generate high-quality experimental data and perform scientific analysis to support formulation and process optimization efforts.
- Apply statistical tools and Design of Experiments (DoE) approaches, with appropriate guidance, to evaluate formulation and process variables.
- Characterize tLNP formulations using relevant analytical and biophysical techniques and collaborate with analytical teams to interpret results.
- Support technology transfer, scale-up activities, and manufacturing readiness assessments by providing laboratory process knowledge and technical documentation.
- Evaluate formulation stability under various storage and stress conditions and contribute to development of clinical in-use strategies.
- Maintain detailed and accurate documentation of experimental procedures, results, and conclusions in electronic laboratory notebooks, technical reports, and presentations.
- Effectively communicate scientific findings and recommendations within project teams and cross-functional meetings.
- Continuously identify opportunities to improve laboratory methods, workflows, and scientific understanding.
- Maintain compliance with safety, quality, and good research practices while ensuring high laboratory productivity.
Qualifications- Scientist I: BS in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biotechnology, Chemistry, Biochemistry, Bioengineering, or a related scientific discipline with typically 5+ years of relevant industry experience, or MS with typically 2+ years of relevant industry experience.
- Scientist II: BS in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biotechnology, Chemistry, Biochemistry, Bioengineering, or a related scientific discipline with typically 7+ years of relevant industry experience, or MS with typically 5+ years of relevant industry experience.
- Fundamental understanding of drug product formulation principles, protein biochemistry, stability, and analytical characterization.
- Demonstrated ability to independently execute experiments, analyze data, troubleshoot technical challenges, and communicate scientific findings.
- Experience with formulation development, process development, or characterization of biologics, nanoparticles, or related drug delivery systems.
- Knowledge of laboratory experimental design, data analysis, and scientific documentation practices.
- Strong written and verbal communication skills and ability to work effectively in multidisciplinary teams.
- Ability to manage multiple priorities and deliver high-quality results within project timelines.
Preferred- Hands-on experience with mRNA, lipid nanoparticles (LNPs), targeted LNP systems, biologics, or advanced drug delivery platforms.
- Experience evaluating formulation stability and stress conditions, including freeze-thaw and frozen-state storage.
- Familiarity with formulation characterization techniques including Dynamic Light Scattering (DLS), Nanoparticle Tracking Analysis (NTA), Differential Scanning Calorimetry (DSC), Microflow Imaging (MFI), chromatography methods (SEC, RP-HPLC, IEX), and UV-Vis spectroscopy.
- Experience performing LNP characterization assays such as particle size analysis, encapsulation efficiency measurements, and ligand-targeting assessments.
- Working knowledge of sterile drug product operations including filtration, aseptic processing, lyophilization, and fill-finish development.
- Experience supporting technology transfer, process scale-up, or manufacturing activities.
- Familiarity with statistical software and Design of Experiments (DoE) methodologies.
- Understanding of relevant ICH, cGMP, and pharmaceutical development principles.
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolutediscretion, consistent with applicable law.
