Scientist, AD Biologics

Position Title: Scientist, AD Biologics

Department: BioTherapeutics Development & Supply, Analytical Development (BTDS AD)

Report to: BTDS ADManagement

Position Summary

The Specialist position is in the Compendial Compliance Team which sits within the Physico-chemical Sciences and Sample Management team as part of the wider BTDS AD Department.

The department is responsible for Clinical Release and Stability Testing for Drug Substance and Drug Product, and Stability Lifecycle management

This role can be either performed on site/ Remote/ Hybrid depending on the business need.

Main duties and responsibilities


* Act as a Large Molecule, Subject Matter Expert (SME) solely responsible for ownership of compendial and particulates methods in maintaining applicable regional compliance.

The scope of the methods encompasses methods such as - pH, Color, Turbidity, Osmolality, Turbidity, Moisture, Extractable Volume, Visible Appearance, Sub-Visible Particulates and MDI, etc.


* Independently write/revise SOP's or other official documentation and reports, when required.


* Keep up to date with existing and new SOP's and official documentation.


* Ability to author the Product Regulatory Section Submissions/Responses to support IND/BLA Filings, as required.


* Lead/deliver the clinical product lifecycle management from Phase I-III with regards to product presentation and formulation changes and manage the co-ordination of the demonstration of method robustness.


* Support the clinical to commercial product transition in relation to method/instrumentation performance and laboratory investigations, as applicable.


* Participate/Lead in Laboratory investigations as applicable.


* Escalation of Compendial Compliance issues to Team Lead in a timely fashion.


* Perform other duties as designated by Management.


* Take an active role in Continuous Improvement, identify and drive improvement initiatives in line with CI Team.


* Ability to advance and shape the BTDS AD Cork technical analytical capabilities in-line with industry standards.



* A 3 rd level qualification in a Biochemistry,Chemistry, Biotechnology, or a related scientific field.


* Customer focus and result driven.


* Knowledge/ previous testing experience of Compendia Testing (pH, Colour, Turbidity, Moisture and Osmolality Analysis and Particulates knowledge (Microflow Imaging, Light Obscuration Sub-Visible and Visible Foreign Analysis).


* Efficient and flexible.


* Previous GMP experience is required.


* Excellent communication skills.


* Proficient in the use of business applications such as MS PowerPoint, MS Word and MS Excel.


* Ability to think logically, proactive approach with ability to work on own initiative.


* High attention to detail.


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

NB: The position description is a general guideline; it does not purport to be an ...