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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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 AbbVies 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 CCSincluding vials, prefilled syringes, and prefilled cartridgeswith 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.

• Bachelors Degree or equivalent education and typically 10 years of experience, Masters 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 CT 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.

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable 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.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html