Scientist II, Drug Product Design & Development

About the role

The Drug Product Design and Development (DPDD) group within AbbVie’s Synthetic Molecule CMC organization designs and develops drug products that enable the delivery of candidate synthetic molecules across clinical development, from proof-of-concept and pivotal studies through life-cycle innovation. DPDD collaborates with cross-functional teams to establish integrated, phase-appropriate drug product development strategies; design and execute studies that deliver bioavailable, stable, and manufacturable drug products; and ensure the timely delivery of clinical supplies. The group also optimizes formulations and manufacturing processes to produce commercially viable drug products for late stage clinical studies that meet patient needs, and support the consistent manufacture of high-quality products. AbbVie’s DPDD organization is seeking a highly motivated, talented Scientist II with experience in developing drug products to join our team in North Chicago, IL. The successful candidate will partner with project leads and cross-functional teams to develop drug delivery and formulation strategies; design, characterize, and build understanding of formulations and processes; and advance the biopharmaceutical characterization of clinical formulations. In this role, the candidate will serve as an integral member of the drug product team, executing activities that support formulation design and drug product process development. The candidate is also expected to foster productive collaborations and communicate effectively with scientific teams and cross-functional stakeholders.

Responsibilities

• Plans and executes formulation feasibility, optimization, and supporting studies for project goals.
• Continuously seeks to improve existing formulation techniques and processes.
• Demonstrate strong proficiency in analytical techniques for physicochemical characterization of drug substances and drug products, including HPLC, X-ray diffraction, particle size distribution (PSD) analysis, and differential scanning calorimetry (DSC).
• Innovates and implements new experimental protocols based on good scientific understanding and acts as a resource for others.
• Interprets data in the framework of the project and modifies experimental plans when required.
• Applies theoretical framework to solve moderately complex formulation and development problems.
• Makes scientific contributions to development reports, technical summaries, and supporting documents.
• Communicates formulation recommendations clearly in a scientifically sound in a project team meeting setting.
• Collaborates across CMC functions to advance project execution.
• Executes biopharmaceutics related assays for guiding the formulation selection and derisking of clinical products, including oral dosage forms and long-acting injectables.
• Interface with drug product development teams to ensure that biopharmaceutical and physicochemical considerations are incorporated into formulation design.