Pharma R&D: Analytical Method Innovator

Eirgen Pharma; Waterford; On-site; EUR 55,000 - 75,000; Full time

Job summary

Eirgen Pharma in Waterford is seeking an Analytical Development & Transfer Chemist (R&D) to support method development, transfer and validation for API and finished products. You will work in a GMP-regulated analytical lab and contribute to regulatory submissions.

The role requires a degree in Analytical Chemistry or Pharmaceutical Science, experience with HPLC/GC/Dissolution, and familiarity with Empower software and E-document systems.

Qualifications

• Experience in GMP-regulated analytical environment.
• Competent in HPLC/GC/Dissolution methods.
• Familiar with Empower software and electronic document management systems.
• Ability to work in a collaborative team and support regulatory submissions.

Responsibilities

• Develop analytical methods for API and finished product testing.
• Perform compatibility studies.
• Conduct method validation and transfer for API and finished products.
• Perform forced degradation studies for API and finished products.
• Establish sink conditions for dissolution studies.
• Assist with submission documentation for regulatory dossiers.
• Participate in or lead laboratory investigations.

Skills

Analytical methods (HPLC/GC/Dissolutn)

GMP-regulated environment

Empower software

Electronic document management

Regulatory submissions knowledge

Education

Bachelor's degree in Analytical Chemistry or Pharmaceutical Science

Tools

Empower Lab Software

Electronic Document Management Systems

Job description

Eirgen Pharma in Waterford is seeking an Analytical Development & Transfer Chemist (R&D) to support method development, transfer and validation for API and finished products. You will work in a GMP-regulated analytical lab and contribute to regulatory submissions.

The role requires a degree in Analytical Chemistry or Pharmaceutical Science, experience with HPLC/GC/Dissolution, and familiarity with Empower software and E-document systems.