Scientist, II - Global Material and Parenteral Packaging Sciences

Role Summary

Scientist II to join the Global Material and Parenteral Packaging Science team, a core component of Product Development Science & Technology. Drive the development of Container Closure Systems (CCS) for novel parenteral and biotechnological products, supporting AbbVie’s strategic pipeline assets. Focus on characterizing CCS components (vials, prefilled syringes, prefilled cartridges) with an emphasis on Container Closure Integrity (CCI); conduct performance analyses, develop and validate analytical methods, provide technical support for CCS qualification, and evaluate cutting-edge techniques.

Responsibilities

• Planning, preparation, execution and evaluation of experiments for development of container closure systems of new parenteral drug products, namely liquid drug preparations of biotechnological drugs in vials, pre-filled syringes and cartridges as well as lyophilizates.
• Subject matter expert for the technical evaluation and implementation of CCI methods as well as continuous improvement based on a holistic CCI strategy and current regulatory requirements.
• Responsibility for development and validation of CCI methods according to GxP requirements.
• Responsibility for transferring ownership and maintaining lab equipment. Ensure required maintenance schedule, proper documentation, and training new users.
• Technical support of the continuous landscaping programs for innovative CCS, including implementation and characterization based on various CCI techniques.
• Initiating and driving collaborations with AbbVie partner labs and/or external labs and manufacturing sites.
• Coordination of suppliers for materials, equipment, and services needed to perform work.
• Documentation of all work according to applicable GxP and internal procedural requirements.
• Authoring comprehensive, scientifically sound reports, e.g. lab reports, development reports or risk assessments that could serve as source documents for authority submissions.
• Mentoring and support for new colleagues and interns/contractors
• Presentation of project data as well as SME topics in internal global teams.
• Compliance with all relevant work safety requirements.

Qualifications

• Required: BS or equivalent education with typically 7 or more years of experience or MS or equivalent education with typically 5 or more years of experience.
• Required: Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions.
• Required: Demonstrated ability to learn, understand and master new experimental techniques.
• Required: Ability to multitask and work within timelines.
• Required: Demonstrated scientific writing skills and strong verbal communication skills.

Preferred Qualifications

• Degree from an accredited University in pharmacy/biology/biotechnology/chemistry/process engineering/material sciences/physics or related areas.
• Good 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.
• Good 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

• BS or equivalent education with typically 7 or more years of experience or MS or equivalent education with typically 5 or more years of experience.