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 biologics drug product development to serve as a principal research 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 formulation and process development, and engineering teams, the Drug Product Pilot Plants, third party manufacturers and AbbVie’s Operations S&T and Commercial Manufacturing functions.
This position can be filled at the Principal Research Scientist I or Senior Scientist II level depending on the candidate’s qualifications and experience.
· Lead matrix drug product teams for one or more projects.
· Lead the design and execution of drug product formulation and process development, and robustness studies.
· Lead scale-up and technology transfer activities to internal and external manufacturing sites.
· Represent Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC team.
· 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.
· Own drug product control strategies.
· Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and line management.
· May supervise and/or mentor junior level scientists and engineers.
For Principal Research Scientist I: Bachelors, Masters, or PhD in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or related disciplines with 14+ (Bachelors), 12+ (Masters), or 6+ (PhD) years of relevant industry experience.
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.
Proven ability to solve critical scientific problems.
Strong experience with biologics formulation and process development.
Experience with drug product process scale-up and tech transfer.
Proven-track record of drug product or CMC team leadership.
Hands-on experience with Design of Experiments (DoE), multivariate statistical analyses and data visualization tools.
Experience with sterile manufacturing unit operations (freeze-thaw, mixing, filtration, filling, and freeze-drying) development and scale-up.
Experience with process modeling is a plus.
Experience with managing third party manufacturers.
Experience with quality risk management and drug product control strategy.
Understanding of relevant cGMP, regulatory guidance, and process safety requirements.
Deep scientific knowledge and significant hands-on experience in biologics formulation and process development.
Effectively communicates to influence without authority, 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.