Principal Research Scientist II, Biologics Drug Product Development

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Biologics Drug Product Development (Bio DPD), a part of Development Sciences within AbbVie’s R&D, is a global organization that is responsible for drug product formulation and process development, and definition of the product presentation for biologics (proteins, conjugates, peptides, neurotoxins etc.) and genetic medicine (AAV, LNPs, Cell Therapy).

AbbVie is seeking a highly motivated candidate for the position of Principal Research Scientist II, located in North Chicago, IL. We are seeking an accomplished scientist with a proven track record in biologics formulation development, characterization and automation. This position will be an integral part of the product development and CMC teams and will have strong collaborations with several stakeholders, including discovery research, analytical research and development, bioprocess development, devices and combination products development, product development science and technology, pilot plants and third-party manufacturers.

Key Responsibilities:

• Lead a group responsible for formulation screening and optimization for a wide range of complex biologics modalities, drug product presentations and routes of administration.
• Develop phase-appropriate formulation screening workflows using medium and high-throughput systems.
• Employ orthogonal analytical tools to characterize the biophysical properties and solution behavior of complex biologics modalities.
• Build, maintain and continuously improve data analysis and visualization workflows for high data volume formulation development experiments.
• Develop and implement AI/ML tools to model the impact of formulation parameters on product quality attributes to inform formulation lock decisions.
• Apply design of experiments (DoE) and advanced statistical analyses for formulation robustness and design space studies.
• Oversee the authoring of product development sections in regulatory filings and interactions.
• Support and/or lead digital transformation initiatives as it relates to biologics formulation development.
• Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes.
• Serve as a drug product team leader for one or more projects and represents Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team.
• Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and line management.
• Support due diligence for business development opportunities as formulation subject matter expert.
• Manage a team of 4-6 scientists and engineers (BSc to PhD level) including other drug product team leaders.
• Responsible for performance management, development plans, and recommendations for promotions and transfers for direct reports.

Qualifications

• Bachelors, Masters, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Bioengineering, Chemical Engineering, or related disciplines with 16+ (Bachelors), 14+ (Masters), or 8+ (PhD) years of relevant industry experience.
• Proven ability to solve critical scientific problems.
• Strong experience with biologics (proteins, conjugates, peptides and/or neurotoxins) pre-formulation, developability, formulation development and biophysical characterization.
• Hands-on experience in developing and deploying data science solutions for scientific problems.  
• Experience as CMC cross-functional matrix team leader.
• People management experience.

​​​​​​​Key Competencies:

• Deep scientific knowledge and significant hands-on experience with biologics formulation development and biophysical characterization.
• Experience and/or formal training/education in data science.
• Effectively communicates to influence without authority, drives technical excellence, and inspires continuous improvement.
• Builds strong relat