Senior Scientist I / II, tLNP Formulation

About the role

The 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.

Responsibilities

• Develop risk-based drug product development strategies for clinical-stage tLNP programs
• Represent the tLNP formulation team in cross-functional forums, guiding program strategy and enabling key CMC deliverables and milestones, including IND- and BLA-enabling activities
• Assess tLNP liabilities under practical worst-case stress conditions to inform excipient selection and formulation screening strategies
• Design and execute comprehensive formulation screening studies, evaluating variables such as pH, buffer, antioxidants, surfactants, cryoprotectants, and other stabilizing excipients
• Lead process development, optimization, and robustness studies, with a focus on sterile fill-finish operations
• Facilitate scale-up, technology transfer, and manufacturing readiness in close collaboration with internal and external stakeholders
• Utilize statistical methods and Design of Experiments (DoE) to optimize formulations and process parameters
• Develop and communicate clinical in-use strategies for investigational products, including assessment of in-use stability for clinical-stage programs
• Plan and conduct experiments to evaluate innovative tLNP product presentations, such as lyophilized forms, spray-dried powders, nonaqueous suspensions, and other advanced formats
• Interpret and present critical data, key findings, and recommendations in both internal and cross-functional team forums
• Maintain high laboratory productivity while ensuring strict adherence to corporate safety, quality, and good research practices
• Practice robust documentation standards by accurately recording experimental data, results, and conclusions in electronic lab notebooks, technical reports, and scientific presentations

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 -20C to -80C) 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