Purpose:

We are seeking a highly skilled Senior Scientist to join our Global Material and Parenteral Packaging Science team, a core component of Product Development Science & Technology (PDS&T). The successful candidate will help lead the development of Container Closure Systems (CCS) for novel parenteral and biotechnological products (NBEs), supporting the advancement of some of AbbVie’s most strategic pipeline assets, including monoclonal antibodies, antibody-drug conjugates, and therapeutic toxins.

In this role, you will be considered a subject matter expert (SME) in characterizing CCS—including vials, prefilled syringes, and prefilled cartridges—with an emphasis on Container Closure Integrity (CCI). You will lead the design and execution of novel scientific methods to critically evaluate container closure performance and integrity using force analyzers, developing and validating analytical methods, providing technical expertise for CCS qualification in pharmaceutical manufacturing, and evaluating and implementing cutting-edge CCI and characterization technologies.

• Leverage deep technical expertise and available characterization data (force/torque, dimensional, material properties) to proactively identify, analyze and resolve key project hurdles and critical assumptions related to CCS design and integrity of new parenteral drug products, namely liquid drug preparations of biotechnological drugs in vials, pre-filled syringes and cartridges as well as lyophilizates.
• Identify and seize opportunities to investigate and incorporate novel CCS materials, components, or integrity technologies that align with the long-term strategy and enhance product stability and manufacturability.  This includes actively contributing to the technical evaluation and implementation of CCIT methods and continuous improvement based on a holistic CCI strategy aligned to current regulatory requirements.
• Responsibility for development and validation of robust CCI methods according to GxP requirements, ensuring they are scientifically sound and fit-for-purpose across all phases of drug development.
• Technical support of the continuous landscaping programs for innovative CCS, including hands-on implementation and comprehensive characterization based on various CCI techniques.
• Initiate and drive strategic technical collaborations with AbbVie partner labs, external contract labs, and manufacturing sites to facilitate method transfer, technology adoption, and successful project delivery.
• Coordination of external suppliers for materials, equipment, and contract services needed to perform work.
• Authoring comprehensive, scientifically sound reports (e.g. lab reports, development reports or risk assessments) that could serve as critical source documents for authority submissions.  Ensure all work is documented according to applicable GxP and internal procedural requirements.
• Take responsibility for transferring ownership and maintaining lab equipment. Ensure required maintenance schedule, proper documentation, and training new users.
• Mentoring and support for new colleagues and interns/contractors to build group expertise.
• Presentation of project data as well as SME topics in internal global teams and effectively communicate technical conclusions and strategic recommendations.
• Compliance with all relevant work safety requirements.

Preferred Qualifications:

• Degree from an accredited University in pharmacy/biology/biotechnology/chemistry/process engineering/material sciences/physics or related areas.
• Bachelor’s Degree or equivalent education and typically, 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD and typically 4 years of experience.
• Possesses thorough technical and scientific understanding of parenteral drug product development and CCI test methods.
• Understanding of relevant scientific literature and ability to apply theoretical framework to solving problems within their scientific discipline in a timely manner.
• Scientific expertise in statistical data analysis
• Knowledge of CAD/3D printing and/or µCT analysis is an advantage.
• Ability to work concurrently on multiple projects, work in teams, and manage priority conflicts.
• Excellent verbal and written communication skills.
• Ability to establish comprehensive scientific and project related documentation.
• Ability to communicate CCI strategies and content to broad audiences internally and externally.
• Strong motivation and proactive approach to lab responsibilities