The Biologics Drug Product Development (Bio DPD) is a global organization within AbbVie that is responsible for developing and characterizing drug product formulations and manufacturing processes for biologics and small molecule injectables from early development through commercialization and life cycle management support.

　　AbbVie is seeking a highly motivated scientist with a proven track record in formulation and process development to serve as a Senior Scientist in the Bio DPD group in Lake County. This position will be an integral part of the product development and CMC teams and will have strong collaborations with the Pre-formulation, analytical, process development functions, the Drug Product Pilot Plants, third party manufacturers and AbbVie’s Operations S&T and Commercial Manufacturing functions.

　　The position can be filled at the Senior Scientist I or Senior Scientist II level depending on the candidates’ qualifications and experiences.

　　Key Responsibilities:

　　· Lead the design and execution of experiments to define and characterize formulations for a wide range of biologics modalities (monoclonal antibodies, bispecific antibodies, antibody drug conjugates, fusion proteins, peptides, AAVs) as well as small molecule injectables.

　　· Serve as a subject matter expert in biologics formulation development (liquid and lyophile).

　　· Lead the design and execution of formulation robustness studies.

　　· Support the design and execution of process development studies for a wide range of processes including freeze-thaw, compounding, mixing, filtration, filling, and freeze-drying.

　　· Support scale-up and technology transfer activities to internal and external manufacturing sites.

　　· Participate in or lead matrix drug product teams for one or more projects.

　　· May represent the Bio DPD function in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC team.

　　· Keep abreast of the latest advances in biologics and sterile products formulation development and lyophilization.

　　· Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and improve business processes.

　　· Effectively and timely communicates study plans, risks and mitigation plans to stakeholder and line management.

　　Basic Qualifications:

　　For Senior Scientist II, Bachelors, Masters, or PhD in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or related disciplines with 11+ (Bachelors), 9+ (Masters), or 3+ (PhD) years of relevant industry experience.

　　For Senior Scientist I, Bachelors, Masters, or PhD in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or related disciplines with 8+ (Bachelors), 6+ (Masters), or 0+ (PhD) years of relevant industry experience.

　　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.

　　Solid understanding of biologics degradation mechanisms and stabilization strategies.

　　Hands-on experience with Design of Experiments (DoE), multivariate statistical analyses and data visualization tools.

　　Experience with formulation development for drying technologies such as spray drying and spray freeze-drying is a plus.

　　Key Competencies:

　　Deep scientific knowledge and significant hands-on experience in biologics formulation.

　　Effectively communicates to influence others, drives technical excellence, and inspires continuous improvement.

　　Builds strong relationships with peers and cross-functional partners to enable higher performance.

　　Connects ideas from disparate fields, integrates data and information quickly, and takes risks to achieve the highest performance.

　　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.

　　AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.