Associate Scientist

PE Global is currently recruiting for Associate Scientist on behalf of our client based in North Dublin: 12 month initial contract - hybrid

Reporting to the Principal Scientist of Analytical Scientific & External Operations (ASEO), the Scientist, will deliver a range of key activities. These include, but are not limited to: management of commercial analytical method transfers and validations of test methods to internal, external and in-market locations; ownership of change controls for global test method or filing changes; support and management of internal and external analytical testing at CMOs and contract labs; and knowledge management across commercial analytical.

Key Responsibilities:

· Own and/or support analytical method transfers and validations in GMP Quality Control labs, both internally and externally – including generation of protocols, reports and acceptance criteria, co-ordination of execution, project management, and provision of program updates to leadership.

· Own and/or support analytical change controls for changes to global test methods or regulatory filings.

· Own and/or support relationships with external organizations for analytical testing supporting manufacture and release of commercial products.

· Provide oversight of external lab testing systems and documentation, and of associated Quality Agreements and change controls, to ensure compliance with requirements and regulatory filings.

· Lead and manage projects with a global mindset to direct and influence multiple remote teams.

· Embody a compliance, quality and continuous improvement mindset; convey urgency and drive issues to closure.

· Create and maintain an environment where employees are fully engaged, willing to speak up, and able to develop and thrive.

Must-have Qualifications:

· Bachelor's degree in Biological Sciences, Chemistry or a related discipline.

· Minimum 5 years' experience in Quality and Compliance organizations.

· Knowledge and experience of the commercial analytical method lifecycle.

· Demonstrated knowledge of analytical methods (in-process, release and stability for late-stage/commercial biologics), and of health authority regulations.

· Experience with analytical change controls in a GMP environment.

· Experience working in cross-functional matrix teams.

· Proficiency in Quality Control and analytical processes and regulations (e.g. cGMP/GDP).

· Thorough understanding of company policies and regulatory requirements and how they relate to the management and documentation of product quality investigations.

· Excellent communication and interpersonal skills, able to interface with internal and external stakeholders at all levels

Nice-to-have Qualifications:

· Advanced degree (MS/PhD) in a science or pharmaceutical-related field – Chemistry, Pharmacy, Biology or Chemical Engineering.

· Experience developing and maintaining the analytics required for development and licensure of biopharmaceuticals.

· Experience authoring and/or reviewing regulatory submissions.

· Direct experience of compliance remediation activities resulting from regulatory actions.

· Experience leading large or complex programs across divisions, business backgrounds and cultures.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up-to-date CV to audrey.mccarthy@peglobal.net