Role Summary
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. The successful candidate will help lead the development of Container Closure Systems for novel parenteral and biotechnological products, supporting the advancement of AbbVie’s strategic pipeline assets. You will be a subject matter expert in characterizing container closure systems, with an emphasis on container closure integrity, leading the design and execution of methodologies to evaluate CCS performance and integrity, developing analytical methods, and providing technical expertise for CCS qualification in pharmaceutical manufacturing.
Responsibilities
- Leverage deep technical expertise and characterization data to proactively identify, analyze and resolve key project hurdles related to CCS design and integrity of new parenteral drug products.
- Investigate and incorporate novel CCS materials, components, or integrity technologies, contributing to the evaluation and implementation of CCIT methods and continuous improvement aligned to regulatory requirements.
- Develop and validate robust CCI methods according to GxP requirements across all phases of drug development.
- Provide technical support for continuous landscaping programs for innovative CCS, including hands-on implementation and comprehensive characterization using various CCI techniques.
- Initiate and drive strategic technical collaborations with partner labs, external contract labs, and manufacturing sites to facilitate method transfer and project delivery.
- Coordinate external suppliers for materials, equipment, and contract services needed to perform work.
- Author comprehensive, scientifically sound reports that could serve as critical source documents for authority submissions, ensuring work is documented according to GxP and internal procedures.
- Transfer ownership and maintain lab equipment, including maintenance schedules, documentation, and training new users.
- Provide mentoring and support for new colleagues and interns/contractors to build group expertise.
- Present project data and SME topics in internal global teams and communicate technical conclusions and strategic recommendations.
- Ensure compliance with all relevant work safety requirements.
Qualifications
- Preferred: Degree from an accredited university in pharmacy/biology/biotechnology/chemistry/process engineering/material sciences/physics or related areas.
- Preferred: Bachelor’s Degree or equivalent with typically 10 years of experience, Master’s Degree or equivalent with typically 8 years, PhD with typically 4 years.
- 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 frameworks to solving problems 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.
Education
- 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 with no experience necessary.