Job Description

Company Description

About AbbVie

AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at  . Follow @abbvie on  LinkedIn, Facebook ,  Instagram ,  X and  YouTube.

Job Description

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.

Responsibility:

• 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.

Qualifications

• 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 no experience necessary.
• Degree from an accredited University in pharmacy/biology/biotechnology/chemistry/process engineering/material sciences/physics or related areas.
• 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
• Possess thorough theoretical and practical understanding of own scientific discipline.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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