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

• 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. PhDs need not apply.
• 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. PhDs need not apply.