Cork: +353 21 4509200 | Dublin: +353 1 5175910
jobs my account call
Search Jobs

Associate Scientist

Quality & Laboratory
Deirdre Duboy
Favourites Share with a friend
Job Reference: JO-2006-65245_1592313504


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.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet - The Talent Group
'Not Just Placers.........Partners'

The Life Science Specialists

View more Jobs in Quality & Laboratory
Share this job with a friend:
Talent Consultant:
Deirdre Duboy
Deirdre Duboy
Talent Consultant
Quality & Laboratory
Ask a question about this job
More jobs from Deirdre Duboy >
View more Jobs in Quality & Laboratory
Share this job with a friend:
Website Design by Dmac Media