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- Serve as a Subject Matter Expert (SME) in analytical techniques including HPLC, HIC, CE, UPLC, and Mass Spectroscopy.
- Plan and perform complex routine and non-routine methods.
- Provide technical guidance and apply expertise to resolve technical issues independently.
- Lead training of staff on technical aspects of the job as required.
- Develop, revise, and implement procedures that comply with regulatory requirements.
- Hold a third-level qualification (Degree) in Biology, Biotechnology, or a related discipline.
- 7+ years of experience in a pharmaceutical/healthcare laboratory.
- Proven experience of leading teams.
- Strong background in Separation techniques.
- Excellent written and verbal communication skills.
- Experience with Track Wise, Change Control Systems, EDMQ, and SAP.
- Knowledge of applicable Regulatory requirements.
- Experience with Regulatory inspections and interacting with inspectors.
Specialist - Qc Separation Sciences - Dublin - Amgen

Description
Job Summary:
This Technical Specialist role leads, coordinates, and facilitates lab operations and compliance without direct supervision. They provide technical expertise on method transfers, continuous improvement, and lean culture, with a focus on Right First Time (RFT). The role represents the QC unit by liaising with internal and external customers.
Key Responsibilities
Additional responsibilities include managing project groups, leading high-performing teams, delivering results, qualifying analytical equipment, and coordinating activities related to method transfers and optimization of Separation Methods.
Requirements
PREFERRED QUALIFICATIONS:
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