Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
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Job Description
We are excited to invite applications for a
Senior Process Specialist/Scientist
to join our
Technical Operations (Pharmaceutical)
team in
AbbVie, North Dublin
on a permanent basis.
This is an exciting and challenging role where you will have technical ownership of commercially launched products and new product introductions to the site (spanning developmental studies and clinical manufacturing up to validation and post-commercialization changes) with a particular focus on the manufacturing process, scale-up, equipment understanding, and statistical evaluations.
Thorough hands-on support of bulk manufacturing, driving production performance KPIs, proactively championing new technologies, and leading troubleshooting investigations – all with a high sense of urgency and high level of technical confidence with full GMP compliance.
Roles and Responsibilities
Continuous oversight with a hands-on mentality on product performance, periodic reviews with senior leadership, and timely authorship of product baseline reports
Leading investigations of process deviations with a high sense of urgency to quantify the potential impact on product quality
Authoring and issuing Batch manufacturing records and technical protocols
Technical support for new product introductions until validation
Applying sound and critical reasoning to troubleshoot complex process challenges
Tracking and trending of product and process data, statistical evaluation of data
Creating and delivering effective and persuasive presentations on complex topics to upper management
Actively drive plant performance, with a special focus on cost improvement programs (CIP)
Function as SME during inspections and audits
Qualifications
Bachelor's degree in Chemistry or a science-related field
Master's degree is desirable
3–5 years relevant experience in a pharmaceutical manufacturing plant and/or training, or an equivalent combination of education and experience
Good understanding of 21 CFR / cGMP documentation and electronic system requirements
Good relationship-building skills with the ability to align individuals and teams to achieve business objectives
Experience managing projects through metrics
Additional Information
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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