Principal Research 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, and definition of product presentation for biologics and genetic medicines. AbbVie seeks a Principal Research Scientist I, located in North Chicago, IL, with a proven track record in biologics drug product formulation development, predictive stability, and quality risk management (QRM). This role will be integral to the product development and CMC teams with collaboration across discovery research, analytical development, bioprocess development, and third-party manufacturers.

Responsibilities

• Serve as subject matter expert in biologics predictive stability modeling, in-use and administration procedures, and QRM.
• Lead the design and execution of biologics drug product formulation development, characterization and robustness studies.
• Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes.
• Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and line management.
• Lead matrix drug product teams for one or more projects and represent Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team.
• Supervise a team of 3-5 scientists and engineers.

Qualifications

• Required: Bachelor’s, Master’s, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with 14+ (Bachelor’s), 12+ (Master’s), or 6+ (PhD) years of relevant industry experience.
• Required: Proven ability to solve critical scientific problems.
• Required: Strong experience with biologics (proteins, conjugates, peptides and/or neurotoxins) and/or genetic medicine (AAV, LNPs, cell therapy) formulation development, and QRM.
• Required: Strong experience in predictive stability modeling (statistical, phenomenological and mechanistic) for different biologics modalities.
• Preferred: Understanding of relevant cGMP and regulatory guidance.
• Preferred: Experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling) development, characterization, scale-up and technology transfer.
• Preferred: Experience in managing third party manufacturers.
• Preferred: Experience with quality risk management and drug product control strategies.
• Preferred: People management experience.

Skills

• Deep scientific knowledge and hands-on experience with predictive stability modeling, administration procedures and risk management.
• Effective communication to influence without authority, drive technical excellence, and inspire continuous improvement.
• Ability to build strong relationships with peers and cross-functional partners to enable higher performance.
• Ability to connect ideas from disparate fields, integrate data quickly, and take calculated risks to achieve high performance.
• Commitment to raising the bar and continuous improvement; fosters a learning environment open to suggestions and experimentation.
• Openness to others’ ideas, fosters innovation, and translates innovation into actionable results.