This job specification outlines the general responsibilities associated with the role of Scientist within the Commercial Attribute Science (CAS) Dept. of Process Development at Amgen Dun Laoghaire (ADL). This role will be responsible for undertaking activities pertaining to Chromatography Analytical Method Troubleshooting, Analytical Method Lifecycle (Method Development, Qualification, Validation, Remediation) and Analytical support for Process Development (PD) activities at the site.

The successful candidate will have proven Chromatography experience acquired in the Pharmaceutical Industry, have a right first-time mindset, be a team player, have a strong understanding of customer service and work with QC colleagues to effectively troubleshoot analytical issues.

The successful candidate will also have a strong understanding of Data Integrity principles and compliance in the laboratory as well as good presentation/influencing skills (Influencing with Data/ Data storytelling). Proven experience with the use of statistical packages to aid analytical method troubleshooting would also be a distinct advantage.

Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.

Key Responsibilities:

• Chromatographic method troubleshooting, development, qualification, validation, bridging, transfer (HPLC/UPLC – CEX,SEC,RP,HIC,HILIC)

• Use of Empower CDS at an advanced level (ability to create report methods, custom fields etc).

• Experience with other analytical techniques would be an advantage (Capillary Electrophoresis, KF titration, compendial methods).

• Act as Technical Lead for the Attribute Sciences function on cross functional teams/programs

• Timely documentation of Analytical data in the electronic notebook system.

• Understanding of data flow in laboratory systems and data integrity.

• Participate in the peer review of analytical data.

• Responsible for providing technical guidance and applying expertise and critical thinking to help resolve technical issues with analytical methods in QC.

• Qualification of analytical equipment and related testing functions.

• Compliance with Standard Operating Procedures for the Attribute Sciences Laboratory.

• Ensure the laboratory is operated in a safe and environmentally friendly manner.

• Ensure ongoing compliance with phase appropriate GMP, including compliance within the LMS training system.

• Ensure high levels of Laboratory housekeeping are maintained including inventory control of samples and consumables.

• Ensure timely completion of Laboratory Investigations, Deviations , PMAFs

• Participate in internal/external audits/inspections as required.

• Plan and implement procedures and systems to maximise operating efficiency.

• Manage and contribute to the achievements of department productivity and goals.

• Engage with the Continuous Improvement Process and MyGreenLab® philosophy.

Qualifications:

• Hold , at a minimum a third level qualification (Degree) in Analytical Chemistry/ Biochemistry or related discipline.

• Have 5-10 years of experience in a pharmaceutical Laboratory running, troubleshooting , developing Chromatography methods (in a PD and/or QC laboratory setting).

Knowledge and Experience:

• Excellent written and verbal communication skills

• Experience with Empower CDS at a poweruser/advanced user level.

• Deep knowledge of chromatography hardware use and maintenance practices

• Experience with Regulatory inspections and interaction with inspectors is preferable.

• Experience working with teams and influencing decisions.

• Skilled in the use of problem-solving tools/techniques

• Experience with developing, validating, troubleshooting, bridging Chromatography methods.

• Understanding of the Change Control and Variation Management Process

• Understanding how the use of statistical tools, such as multivariate analysis can aid method troubleshooting.

• Strong background in General Analytical Chemistry/ Compendial Techniques such as Appearance, Colour, Clarity, ph, Sub Visible Particle testing, Osmolality, KF Titration is preferred but not essential.

• Strong background in Capillary Electrophoresis methods is preferred but not essential

• Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.