Associate Scientist

Associate Scientist - Analytical Method Transfer & Validation

Location: Dublin, Ireland - Onsite

Contract: 12 months

Rate: €29.87 per hour

We are seeking an experienced Associate Scientist to support commercial biologics analytical activities, with a focus on analytical method transfer and validation, GMP QC testing, change control and external laboratory oversight.

Key Responsibilities

• Lead and support analytical method transfers and validations within internal and external GMP QC laboratories.
• Prepare and review protocols, reports and acceptance criteria.
• Manage analytical change controls relating to test methods and regulatory filing changes.
• Coordinate analytical testing supporting commercial product release, stability and in-process testing.
• Provide oversight of CMOs and contract laboratories, including documentation and Quality Agreements.
• Work cross-functionally with QC, QA, Regulatory, Manufacturing and Supply Chain teams.

Requirements

• Degree in Biological Sciences, Chemistry or a related scientific discipline.
• 5+ years' experience in GMP Analytical Sciences or Quality Control laboratories within pharmaceutical/biopharmaceutical manufacturing.
• Direct experience with analytical method transfer and/or method validation for biologic products is essential.
• Experience with analytical methods used for in-process, release and stability testing of late-stage or commercial biologics.
• Experience managing or supporting analytical change controls within a GMP environment.
• Strong knowledge of GMP QC processes, analytical documentation and regulatory requirements.
• Strong project coordination, communication and cross-functional stakeholder-management skills.
• Experience working with CMOs, contract laboratories or external testing partners is advantageous.