Scientist, II - Global Material and Parenteral Packaging Sciences

ICompany Description
Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Purpose:

We are seeking a highly skilled Scientist II 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 drive the development of Container Closure Systems (CCS) for novel parenteral and biotechnological products (NBEs), supporting the advancement of some of Abb Vie's most strategic pipeline assets, including monoclonal antibodies, antibody-drug conjugates, and therapeutic toxins.

In this role, you will leverage your expertise in characterizing CCS-encompassing vials, prefilled syringes, and prefilled cartridges-with a strong focus on Container Closure Integrity (CCI). Your responsibilities will include conducting performance analyses using force analyzers, developing and validating analytical methods, providing technical support for CCS qualification in pharmaceutical manufacturing, and evaluating and implementing cutting-edge techniques.

• 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 Abb Vie 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.

• 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

• 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.
• Demonstrated ability to…