Quality , Science, Pharmaceutical & Food
Associate Scientific Compendial Compliance
- Full Time
currently recruiting for an Associate Scientist Compendial Compliance for a leading Pharma client based in Cork.
- Subject Matter Expert: 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.
- Clinical Product Lifecycle Management: 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.
- Regulatory Filings: Ability to author the Product Regulatory Section Submissions/Responses to support IND/BLA Filings, as required.
- Ability to advance and shape the BTDS AD Cork technical analytical capabilities in-line with industry standards.
- A degree or diploma in chemistry or a related discipline
- 3rd Level qualification in science, administration or other relevant disciplines is preferable
- 3 years’ experience in a relevant testing/Compendial role
- The successful candidate will be a motivated self-starter, capable of working under their own initiative
- Excellent interpersonal and verbal and written communication skills are essential for this role.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Niamh on +353 21 4520313 or alternatively send an up to date CV to Niamh.firstname.lastname@example.org
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***