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Client:
Eurofins Ireland PSS
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Job Category:
Other
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EU work permit required:
Yes
Job Reference:
f23d3106af6f
Job Views:
6
Posted:
24.01.2025
Expiry Date:
10.03.2025
Job Description:
The main purpose of the Standardised Methods Specialist role will be to support the BTDS-AD team in Compendial Compliance acting as Subject Matter Expert (SME) solely responsible for ownership of compendial and particulates methods in maintaining applicable regional compliance.
Job Responsibilities
* Act as a Large Molecule Subject Matter Expert (SME) responsible for ownership of compendial and particulates methods in maintaining applicable regional compliance.
* The scope of the methods encompasses methods such as pH, Color, Turbidity, Osmolality, Moisture, Extractable Volume, Visible Appearance, Sub-Visible Particulates, and MDI.
* Lead/deliver the clinical product lifecycle management from Phase I-III regarding product presentation and formulation changes and manage the coordination of the demonstration of method robustness.
* Support the clinical to commercial product transition in relation to method/instrumentation performance and laboratory investigations, as applicable.
* Ability to author the Product Regulatory Section Submissions/Responses to support IND/BLA Filings, as required.
* Advance and shape the BTDS AD Cork technical analytical capabilities in line with industry standards.
Qualifications
* A degree or diploma in chemistry or a related discipline
* 3rd Level qualification in science, administration or other relevant disciplines is preferable
* 3 years’ experience in a relevant testing/Compendial role
* Motivated self-starter, capable of working under their own initiative
* Excellent interpersonal and verbal and written communication skills are essential for this role.
Additional Information
* This is an opportunity to join Eurofins on a full-time permanent basis.
* Working a flexible 39-hour week.
* Benefits of pension contribution, medical insurance, health insurance, and bonus are included in the package.
* Eurofins Management and Team on client site for support.
* Opportunity to get to know fantastic people and be part of a great team.
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories.
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