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Associate Scientist (Stability Science)

  • Job reference: 931150
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 16/06/2020

Position Summary:
Reporting to Senior Scientist, Late Development and Stability Sciences, Clinical Release and Stability Dept., the person represents BioTD AD in the Global Analytical Forums, will participate and lead on various projects, analytical techniques and testing issues in support of clinical release and stability testing.

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.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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