Scientist I, Biologics Drug Product Development

Role Summary

Biologics Drug Product Development (Bio DPD) is a global organization responsible for drug product formulation and process development for biologics and genetic medicines. AbbVie seeks a Scientist I in North Chicago, IL with experience in Biologics Formulation and Drug Product Development to contribute to developing and delivering biologics drug products.

Responsibilities

• Independently design, execute and interpret critical experiments to answer scientific questions. Understand the broad objectives of the project as well as their role in achieving those objectives, and modify experimental plan when required, to respond.
• Support development projects with hands-on laboratory experimentation, data generation, and analysis of results. As needed, provide support for technical transfer and scale-up of laboratory process knowledge to manufacturing sites.
• Learn, understand and master new experimental techniques and develop proficiency in techniques, and act as a resource or mentor for others.
• Innovate and implement new experimental protocols.
• Demonstrate a high level of proficiency in his/her field.
• Set and meet experimental and project timelines in accordance with CMC strategy.
• Effectively organize and present scientific plans and data. Maintain detailed and organized electronic laboratory notebook, and compile data into scientific presentations and reports to support project goals.
• Contribute to writing and conceptual framework of publications, presentations, and patents.
• Routinely read and apply relevant scientific literature. Impact projects mostly through lab and/or pilot plant based activities where applicable.

Qualifications

• Required: BS or equivalent education in Chemistry, Biochemistry, Chemical Engineering, Bioengineering, Pharmaceutical science, or related field with typically 5+ years of experience, or MS or equivalent education with 2+ years of experience.
• Theoretical and practical knowledge of protein biochemistry, stability, and analytics.
• Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions.
• Demonstrated ability to learn, understand and master new experimental techniques.
• Ability to multitask and work within timelines.
• Demonstrated scientific writing skills and strong verbal communication skills.

Preferred Qualifications

• Experience with biologics (proteins, conjugates, peptides and/or neurotoxins) and/or genetic medicine (AAV, LNPs, cell therapy) formulation development, in-use studies, and DP process development.
• Hands-on experience with biologics or genetic drug product preparation and analysis, e.g. HPLC/UPLC, UV-Vis spectroscopy, CE-SDS, icIEF, HIAC, MFI, DLS, DSC, etc.
• Knowledge of Design of Experiment (DoE), data analysis and experience of statistical software packages is preferred.
• Understanding of relevant cGMP and regulatory guidance.
• Experience with sterile manufacturing unit operations (freeze-thaw, mixing, filtration, filling, and freeze-drying) development and characterization
• Ability to multitask and meet timelines in a dynamic environment.