Scientist II, Process Development

Responsibilities

• Formulation Development for FIH Programs
• Act as a technical expert in biologic (mAbcs, ADCs, LNPS, toxins) drug product formulation, independently designing, executing, and interpreting formulation development studies to enable FIH and early clinical studies in a phase-appropriate manner.
• Investigate, identify, develop, and optimize formulation and drug product development approaches (liquid and lyophilized) for biologic therapeutics, continuously seeking to improve existing laboratory analytical methods and assays to accelerate development timelines.
• Routinely read and apply relevant scientific literature to inform formulation approaches; contribute to the conceptual framework of scientific reports, presentations, and patents.
• Drug Product Processing & Filling Support
• Execute drug product processing and filling activities, including hands-on operation of fillers, liquid handlers, lyophilizers, and related equipment as part of the Centralized Process Operations team.
• Independently design and conduct drug product process development studies to characterize manufacturability and ensure scalable, reproducible processes when necessary.
• Implement and innovate new experimental protocols and techniques to enhance process understanding and product quality.
• Clinical In-Use Compatibility & Administration Evaluation
• Independently design, execute, and interpret in-use stability and compatibility studies to ensure accurate and safe clinical dose administration.
• Evaluate compatibility of biologic formulations with clinical administration devices and diluents to support FIH and early-phase clinical trial requirements.
• Modify experimental plans in response to emerging project needs, in alignment with project leads and key stakeholders.
• Scientific Excellence & Collaboration
• Understand the broad objectives of the project and the role of drug product development in achieving those objectives; proactively adjust experimental plans as project priorities evolve.
• Set and meet experimental timelines through lab-based activities; demonstrate strong multitasking and planning skills in a fast-paced, deadline-driven environment.
• Understand CMC and drug product development requirements; work efficiently and collaboratively across functions toward project timelines and goals.
• Learn, understand, and master new experimental techniques; act as a resource for colleagues.
• Generate high-quality data based on sound scientific principles; document results thoroughly in an electronic lab notebook.
• Effectively organize and present scientific plans and data in team meetings, formal presentations, and written reports.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, and GxP compliance where applicable.
• Bachelor's Degree in Chemistry, Biochemistry, Biology, Chemical Engineering, Pharmaceutical Sciences, or equivalent with typically 7 or more years of relevant industry experience; or Master's Degree or equivalent education with typically 5 or more years of industry experience.
• Demonstrated experience in biologic formulation development for liquid and/or lyophilized drug products.
• Hands-on experience with analytical techniques used for protein characterization and stability testing (e.g., SEC, RP-HPLC, CE-SDS, icIEF, HIAC, MFI, DLS, SoloVPE or equivalent).
• Hands-on experience with drug product processing and filling equipment (e.g., fillers, liquid handlers, lyophilizers).
• Experience with in-use stability and/or clinical compatibility studies for biologic drug products preferred.
• Demonstrated ability to independently design, execute, and interpret critical experiments to answer scientific questions.
• Demonstrated ability to learn, understand, and master new experimental techniques and independently troubleshoot issues in the lab with good jud

Additional Information

The Drug Product Development group within AbbVie is a global organization responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics (antibodies, antibody-drug conjugates (ADCs), neurotoxins, and novel biologic formats) from preclinical development through clinical proof of concept. We have an exciting opportunity for a Scientist II to join our team. This role is an onsite, lab-based position requiring daily, hands-on scientific work and face-to-face cross-functional collaboration. The successful candidate will serve as a technical expert in biologic drug product development, with a primary focus on developing formulations to enable First-in-Human (FIH) clinical studies, supporting drug product processing and filling activities, and evaluating clinical in-use compatibility and administration. This role is an onsite role in a lab-based function. To be successful candidates must enjoy and thrive in an onsite, highly collaborative lab environment with daily face-to-face cross functional interactions between scientists.

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