Senior Scientist I, Biologics Drug Product Development

Job Description

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). AbbVie is seeking a highly motivated candidate for the position of Senior Scientist I, Biologics Drug Product Development, located in North Chicago, IL. We are seeking an accomplished scientist with a proven track record in biologics formulation and process development, and characterization. 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, combination products development, science and technology, pilot plants and third-party manufacturers.

Key Responsibilities

• Develop and apply biophysical characterization strategies to assess molecular properties, stability, aggregation, and formulation performance to support product development decisions.
• Apply a strong understanding of the formulation and analytical challenges associated with ultra-high-concentration biologics and co-formulations, including their impact on stability, viscosity, manufacturability, and product performance.
• Support scale-up and technology transfer activities to internal and external manufacturing sites.
• Utilize automation and high throughput screening technologies to accelerate biologics formulation development and enable efficient evaluation of multiple formulation variables.
• Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
• Keep abreast of the latest advances in biologics formulation and process technologies.
• Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and improve business processes.
• May represent the Bio DPD function in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC team.
• Effectively and timely communicates study plans, risks and mitigation plans to stakeholder and line management.

Qualifications

• Bachelors, Masters, or PhD in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or related disciplines with 8+ (Bachelors), 6+ (Masters), or 0-4+ (PhD) years of relevant industry experience, is required.
• Proven ability to solve critical scientific problems.
• Hands-on experience with biologics formulation development and lyophilization.
• Hands-on experience with analytical and biophysical characterization of proteins and solid-state characterization methods.
• Experience with automation technologies and/or high-throughput screening methods for formulation development.
• Solid understanding of biologics degradation mechanisms and stabilization strategies.
• Hands-on experience with Design of Experiments (DoE), multivariate statistical analyses and data visualization tools.

Preferred Qualifications

• Understanding of relevant cGMP and regulatory guidance.
• Experience with sterile manufacturing unit operations (freeze-thaw, mixing, filtration, filling, and freeze-drying) development, characterization, scale-up and technology transfer.
• Experience in managing third party manufacturers.
• Experience with quality risk management and drug product control strategies.