Associate Scientist

Next Generation; Dublin; On-site; EUR 72,752,000 - 98,443,000; Full time

Job summary

Next Generation in Dublin, Ireland is seeking an experienced Associate Scientist to support commercial biologics analytical activities, focusing on analytical method transfer and validation, GMP QC testing, and external laboratory oversight.

You will lead transfers, prepare protocols, manage change controls, coordinate testing for release and stability, and work cross-functionally with QC, QA, Regulatory, Manufacturing and Supply Chain teams.

Qualifications

• Degree in Biological Sciences, Chemistry or a related science.
• 5+ years' experience in GMP Analytical Sciences or QC labs in pharma.
• Direct experience with analytical method transfer and/or validation for biologics.
• Experience with in-process, release and stability testing of late-stage/ commercial biologics.
• Experience managing analytical change controls in GMP.
• Strong GMP QC knowledge and regulatory documentation.
• Strong project coordination and cross-functional stakeholder skills.
• Experience working with CMOs or external testing partners (advantageous).

Responsibilities

• Lead analytical method transfers and validations in internal and external GMP QC labs.
• Prepare and review protocols, reports and acceptance criteria.
• Manage analytical change controls in GMP environment.
• Coordinate analytical testing for commercial release, stability and in-process testing.
• Oversee CMOs and contract laboratories, including documentation and quality agreements.
• Work cross-functionally with QC, QA, Regulatory, Manufacturing and Supply Chain teams.

Skills

GMP Analytical Sciences

Method transfer

Method validation

Cross-functional coordination

Education

Biological/Chemistry degree

Job description

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.