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Associate Scientist

Quality & Laboratory
Cork
Deirdre Duboy
Temporary
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Job Reference: JO-2006-65245_1592313504

Summary:

Main duties and responsibilities:


* Apply analytical knowledge to interpretation of generated data and ensure high quality of the delivered results working with senior colleagues in AD.


* Overall release and stability management of product(s) according to portfolio: Evaluate chemical and physical trends. Assist in drawing conclusions on shelf-life, retest period and storage instructions under the guidance of the Scientific Integrator.


* Participate in projects as single point of contact building product stability expertise.


* Takes Lead on critical Lab Continuous Improvement projects and/or serve as representative on cross functional/Process teams.


* Write SOP's, protocols, reports and IMPD/IND regulatory filing documents.


* Proactively identifies and drives process improvements.


* Acts as subject matter expert on assigned analytical techniques..


* Presents technical analytical data clearly and concisely to customers, i.e., internal and external regulatory inspections.


* Keeps abreast of analytical technology and compliance trends.


* Execute assigned NME transfer programs and related projects.



Key Skills and Competencies required:


* Innovative solutions/technical skills to troubleshoot laboratory issues.


* Customer focus and results and performance driven


* Sense of Urgency


* Ability to work well within team structures and provide leadership.


* Solid knowledge of physical, chemical and biological techniques is required.


* Excellent communication skills


* Good scientific and technical writing skills



Education and Experience:


* A minimum of a Bachelor's degree in Biology, Pharmacy or related scientific field is required


* At least 3 years experience or related post graduate academic experience is required.


* Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.


* Practical analytical laboratory experience in a GMP environment is required.




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Talent Consultant:
Deirdre Duboy
Deirdre Duboy
Talent Consultant
Quality & Laboratory
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