Scientist, II - Global Material and Parenteral Packaging Sciences

Role Summary

Scientist II to join Global Material and Parenteral Packaging Sciences, supporting development of Container Closure Systems for parenteral and biotechnological products, with focus on Container Closure Integrity.

Responsibilities include characterizing CCS (vials, prefilled syringes, cartridges), performing performance analyses, developing and validating analytical methods, and providing technical support for CCS qualification in manufacturing.

Responsibilities

• Planning, preparation, execution and evaluation of experiments for development of container closure systems of new parenteral drug products, including liquids in vials, pre-filled syringes, cartridges, and lyophilizates.
• Subject matter expert for technical evaluation and implementation of CCI methods and continuous improvement based on holistic CCI strategy and regulatory requirements.
• Development and validation of CCI methods according to GxP requirements.
• Transferring ownership and maintaining lab equipment; ensure maintenance schedules, proper documentation, and training new users.
• Technical support of continuous landscaping programs for innovative CCS, including implementation and characterization based on various CCI techniques.
• Initiating and driving collaborations with AbbVie partner labs and external labs and manufacturing sites.
• Coordination of suppliers for materials, equipment, and services needed to perform work.
• Documentation of all work according to GxP and internal procedures.
• Authoring scientific reports, lab reports, development reports or risk assessments for authority submissions.
• Mentoring and support for new colleagues and interns/contractors.
• Presentation of project data and SME topics in internal global teams.
• Compliance with all relevant work safety requirements.

Qualifications

• BS or equivalent with typically 7+ years of experience or MS with typically 5+ years of experience.
• Demonstrated ability to independently design, execute and interpret critical experiments; learn and master new techniques; multitask and meet timelines.
• Demonstrated scientific writing and strong verbal communication skills.

Preferred Qualifications

• Degree in pharmacy/biology/biotechnology/chemistry/process engineering/material sciences/physics or related.
• Technical and scientific understanding of parenteral drug product development and CCI test methods.
• Ability to apply scientific literature to solve problems; statistical data analysis expertise.
• Knowledge of CAD/3D printing and/or ¬µCT analysis.
• Ability to manage multiple projects, work in teams, and handle priority conflicts.
• Strong documentation and communication skills, including ability to convey CCI strategies to broad audiences.
• Motivation and proactive approach to lab responsibilities.