We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
•Reporting to the Team Lead, Bioassay BioTD-AD Cork, the person will be focused executing analytical procedures for release & stability testing and process characterization in the early development portfolio.
•The successful candidate will also be responsible for the resolution of testing related issues in support the Bioassay and Early Development Stability Sciences team
• Project Management of Stability Studies
• Authoring, reviewing and approving of stability protocols and procedures
• Trending of stability data
• Communication of project information, goals and objectives
• Participation in global analytical project teams
• Provide technical leadership to the Gene Therapy area personnel.
• Analytical technology transfer, including co-validation/qualification.
• Troubleshooting and investigations
• Drive continuous improvement initiatives
• Remain current regarding therapeutic protein and gene therapy methodologies, technologies and stability studies
KEY SKILLS & EXPERIENCE
• Strong problem-solving skills
• Very strong communication skills (verbal, written & presentation)
• Project management
• Analytical Technology Transfer (equipment procurement and qualification, method qualification/validation).
• Familiar with applicable cGMP and other business compliance regulations.
• Customer focus and results and performance driven.
• Sense of Urgency.
• Ability to work well within team structures and provide leadership.
• A minimum of a Master’s or PhD degree in Virology, Immunology, Genetics, Biochemistry or related scientific field is required.
• 3+ years of experience in academia, biotechnology, or pharma industry with a prima.
• Knowledge of computer programs such as MS Word, Excel, Minitab and Tableau.
• Good understanding of quality and attention to detail.