Job Details: Associate Scientist/Stability Science


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Associate Scientist/Stability Science
Position: Associate Scientist (Stability Science)

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&#**Apply on the website**;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&#**Apply on the website**;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 Position: Associate Scientist (Stability Science)

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&#**Apply on the website**;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&#**Apply on the website**;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

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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