Overview
A global medical device company is looking for an R&D Analyst to join their Research and Development team on a contract basis. This role focuses on analytical lab test method development, verification, and validation for a new Class III combination product. Key testing areas include HPLC, Dissolution, and GPC. Experience with hydrogels, polymers, injections of liquid materials and analytical testing of the product is required.
Responsibilities
* Perform analytical test method development, verification, and validation for injectables, hydrogels, polymers, and related products in a GLP environment.
* Develop, verify, and validate analytical test methods (HPLC, Dissolution, GPC) and troubleshoot related methods and equipment issues.
* Review analytical protocols, data, and reports; assess lot release data as part of analytical testing.
* Collaborate with the R&D team to ensure methods meet regulatory and project requirements.
* Maintain compliance with applicable guidelines (USP, ICH) for HPLC, Dissolution, and other analytical methods.
Qualifications
* 5+ years' experience in analytical lab test method development, verification, and validation.
* Experience in development, verification, and validation of analytical test methods for injectables, hydrogels, polymers, etc.
* Hands-on experience with HPLC, Dissolution, GPC method development and validation.
* Experience troubleshooting issues with HPLC, Dissolution, GPC methods and equipment.
* Experience in developing analytical tests such as Karl Fischer, NMR, GC, DSC.
* Experience in GLP environments.
* Experience reviewing analytical protocols, reports, and data; experience reviewing lot release data.
* Strong understanding of USP and ICH guidelines for HPLC, Dissolution, and other analytical test methods.
The start date is ASAP/1 September. Initial contract length is 12 months, with options to extend. The role is based in Limerick and requires 5 days onsite per week, with occasional remote work when the project allows. The rate is €35-€45 per hour, depending on experience; expenses can be factored into the rate upon discussion.
If you are interested, please send your latest CV and I will call you to discuss further details.
Real Staffing, a trading division of SThree Partnership LLP, is acting as an Employment Business in relation to this vacancy. Equal opportunity employer. Registered address: 8 Bishopsgate, London, EC2N 4BQ, United Kingdom. Partnership Number OC387148 England and Wales.
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