Scientist I/II, Biologics Drug Product Development

About the Role

Biologics Drug Product Development (Bio DPD), a part of Development Sciences within AbbVie's R&D, is a global organization responsible for drug product formulation and process development, and definition of the product presentation for biologics (proteins, conjugates, peptides, etc.) and genetic medicine (AAV, LNPs, Cell Therapy). We are seeking a scientist with experience in Biologics Formulation and Drug Product Development.

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

Scientist II: BS or equivalent education with 7 or more years of experience or MS or equivalent education with 5 or more years of experience.

Scientist I: BS or equivalent education with 5 or more years of experience or MS or equivalent education with 3 or more years of experience.

• 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 Skills

• Experience with biologics (proteins, conjugates and/or peptides) formulation development, in-use studies, and DP process development.
• Experience with sterile manufacturing unit operations (freeze-thaw, mixing, filtration, filling, and freeze-drying) development and characterization.
• Experience with scale-down models, simulation, scale-up, and technology transfer.
• Hands-on experience with biologics drug product manufacturing, 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.
• Ability to multitask and meet timelines in a dynamic environment.

Pay & Benefits

• Compensation range based on job grade and geographic location
• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs