Analytical Chemist

Eli Lilly

Kinsale, Ireland

Main Purpose and Objectives of Position:

The analytical chemist role will provide technical oversight for the analytical methods, equipment and required testing and results associated with manufacturing and raw materials. Responsible for ensuring that materials and products are analysed in accordance with current Good Manufacturing Practice and meet all required quality standards both during and on completion of analysis. Ensures that site and corporate quality policies related to the analysis of GMP materials are followed.

Educational Requirements:

BSc/MSc/PhD in Analytical Chemistry, Biochemistry or a Science related subject.

Additional Requirements:

Minimum of five years relevant analytical chemistry experience in a GMP manufacturing site.

Key Responsibilities for Analytical Chemist Role:

Execute and/or provide technical oversight on the writing of analytical methods, method validations/verifications/transfers and procedure. Ensure all validations/verifications/transfers are in line with current expectations, standards and the analytical control strategy.
Ensure that appropriate analytical technology is used for new and existing, processes and equipment to the site. Develop and validate the appropriate technology and facilitate transfer of analytical methods to & from other manufacturing sites & development organisation.
Assure that all raw materials, in-process samples, intermediates or final products are appropriately analysed and authorised. In the event of non-conformance to acceptable quality and/or safety standards, ensure appropriate investigations are undertaken and documented, using Root Cause Analysis techniques where appropriate. Ensure all associated countermeasures are complete.
Prepare/Review the analytical sections of regulatory documents e.g. RCDs, Monographs, Dossiers and ensure full compliance to these requirements.
Review and approve analytical procedures, investigations, and deviations.
Own and review change controls pertaining to analytical methods, procedures and equipment.
Provide technical support to Lab analysts and other technical staff, providing guidance and training to team members on updates to the cGMPs, which pertain to validations and testing.
Support the writing of Annual Product Reviews (APRs) on Active Pharmaceutical Ingredients and Laboratory Periodic Review Reports (PRRs).
Source, purchase, install and qualify analytical equipment in accordance with local procedure.
Support and participate in self-inspection or other audits with particular reference to the analytical aspects of cGMPs as defined by the Health Authorities, Food and Drug Administration, etc.
Work with onsite technical teams to improve the state of validation and drive variability reduction.
Benchmark best practices for analytical technology and operations and implement appropriate improvements.
Where required, interact with contract suppliers to oversee the delivery of new and existing analytical methods and testing services.

Attributes for the Role:

Demonstrated excellent analytical technical and problem-solving skills.
Demonstrated expertise in a variety of analytical techniques, including chromatography, process analytical technology (PAT), mass spectrometry and physical chemistry technologies.
Pragmatic approach to the solution of technical and business problems.
Demonstrated strong interpersonal skills.
Demonstrated strong verbal and written communication skills.
Demonstrated ability to participate in and facilitate decision-making.
Good IT skills and knowledge of standard software packages (e.g. Microsoft Word, Excel, SAP, Darwin).
Demonstrated good planning and organisational skills, ability to prioritise tasks, commitment to task completion and timelines.
Demonstrated initiative – able to work proactively without direct supervision, continuous improvement mind-set.

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