Senior Scientist II – Biologics Drug Product Development Full-time

Biologics Cmc Developability Scientist

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

The Development Sciences Biologics Drug Product Development organization within AbbVie develops and characterizes drug product formulations and manufacturing processes to provide clinical dosage forms to enable the development of AbbVie's pipeline. AbbVie is seeking a highly motivated person to join the Biologics CMC Developability Team. The candidate will leverage mass spectrometry and other advanced characterization techniques to support the early-stage assessment of candidates coming out of the Discovery pipeline with the opportunity to influence the design and development of stable drug product formulation and manufacturing processes for biologics used in clinical trials. In addition, the candidate will be expected to drive key scientific initiatives and lead innovative approaches to improve current workflows. In this role, the candidate will be a member of a global team and will work closely with scientists from multiple functional areas, including Discovery, Analytical, Process R&D, and Product Development Science & Technology.

Key Responsibilities:

• Lead developability assessment activities, including candidate screening and selection for clinical studies of monoclonal antibodies, antibody drug conjugates, bispecifics, and fusion proteins.
• Utilize analytical instruments to understand structural stability of biotherapeutic entities to influence candidate protein sequence design and selection.
• Develop independent research ideas and pursue scientific questions to continually improve developability approaches. Present data at internal and external professional conferences and prepare manuscripts for publication in peer reviewed journals or patent applications.
• Build and manage strategic alignments with key stakeholders, revise and improve business workflows, manage project timelines and resources. Develops the optimal CMC development path for assigned discovery projects together with clients from various R&D functions with an emphasis on collaboration, quality and with a sense of urgency.

Qualifications:

• Bachelor's Degree or equivalent education and typically 12 years of experience OR Master's Degree or equivalent education and typically 10 years of experience OR PhD and typically 4 years of experience.
• At least 2 years of industry experience in CMC Development of biotherapeutics are preferred
• Deep understanding of protein stability characterization (e.g., SEC, IEX, HIC, CE)
• Additional robotics expertise and digital data capture experience is beneficial
• Knowledge of functional excipient degradation pathways is a plus
• Solid understanding of the scientific approaches to develop commercially viable protein drug products

Key Competencies:

• Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance.
• Excellent oral communication skills in a scientific setting as well as sound technical writing and documentation competencies are required.
• The candidate must be able to work independently, respond to changing priorities and short lead times for multiple tasks; able to identify problems and work toward solutions.
• Raises the bar and is never satisfied with the status quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.