Pharmaceutical Technology Specialist III

Pharmaceutical Technology Specialist III

AbbVie

Westport, Ireland

In this role, you will lead technical support activities across our small molecule products, existing eyecare (unit dose and multidose) and new product technologies. As our technical expert, you will provide strong scientific leadership for all aspects of technology transfer, process scale-up, process monitoring and process troubleshooting for active pharmaceutical ingredient products (API) and drug product commercial manufacturing activities. You will also be involved in leading cross-functional teams to support process development and technology transfer of products for clinical supply and successful regulatory approval of new product submissions.

Roles and Responsibilities

• Participate in and/or lead cross-functional teams with other functions, including R&D, Engineering, Quality, Supply Chain, Operations and Validation.
• Support process development and technology transfer of products for clinical supply and successful regulatory approval of new product submissions.
• Provide strong scientific leadership for ongoing marketed commercial products providing technical support and expertise to troubleshoot and lead investigational enquiries where necessary.
• Review and/or authoring of technical documents, including protocols, reports, batch manufacturing documents and CMC sections of regulatory dossiers.
• Management of high-quality products within project timelines and on budget.
• Clear and effective communication of ideas and results, written and verbal, to technical and non-technical audiences.
• Active contribution of functional area continuous improvement initiatives.
• Represent Pharmaceutical Technical team on cross-functional project teams as needed.

Qualifications

• Bachelor’s degree in chemistry, pharmacy, engineering or a related scientific field, an advanced degree is preferred.
• 8+ years in the pharmaceutical or medical device industry.
• Prior knowledge of aseptic processing is an advantage.
• Strong knowledge of drug product manufacturing and validation, quality systems and regulatory guidelines.
• Well-developed technical writing, organisational, communication and presentation skills required.
• Experience acting as an individual contributor and working well in project and team-based environments.

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