LSC have a great contract opportunity for a Associate Scientist to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have 5 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - 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.
- 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.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A PhD, MSc or BSc in biological sciences, chemistry or related scientific disciplines is essential.
- 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 in method qualification and/or validation with extensive familiarity with regulatory guidelines and cGMP laboratory processes.
Apply via this advert or contact Jenny Murphy on 021 4777329 if you have any more questions about this role!
You will need to hold a Stamp 1G/Stamp 4 visa to apply. LSC do not provide work permit/visa sponsorship.
