R&D Analyst

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

Analytical Development & Transfer Chemist (R&D)

Reach your career goals with Eirgen Pharma, your future could be here!

Would you like to be part of a company that has the courage, innovation, and capability to improve and enhance patient lives across the globe?

Founded in 2005, Eirgen Pharma employs over 180 people in Waterford. We combine the agility of a small company with the ambition to deliver high-quality medicines globally — all within a collaborative, people-focused culture.

About this Opportunity

You will support product development and clinical supply by troubleshooting, developing, transferring or validating analytical test methods. If you have HPLC/GC - testing, method development and validation experience ideally from pharma or related industry this role could be for you.

Key Responsibilities

• Develop analytical methods for API and finished product testing.
• Perform compatibility studies.
• Conduct method validation and method transfer for API and finished products.
• Perform forced degradation studies for API and finished products.
• Establish sink conditions for dissolution studies.
• Perform photostability and in-use stability studies.
• Draft and review test methods, validation protocols and reports as applicable.
• Prepare submission documentation in support of license applications.
• Participate in or lead laboratory investigations.
• Liaise with customers and contract laboratories and attend conference calls as required.
• Assist in preparation for customer and regulatory inspections.
• Identify and recommend improvements within or outside the department to support continuous improvement.
• Analyse raw materials, in-process samples and finished products in a timely and efficient manner to ensure product quality and efficacy.
• Ensure all work is carried out in compliance with company, cGxP, SOPs, regulatory requirements, safety and environmental guidelines.
• Support the team by ensuring all analytical data associated with method development, transfer, validation and testing is reviewed in accordance with cGxP.

About you

• Minimum degree level in Analytical Chemistry/Pharmaceutical Science or a related discipline
• Experience in a GMP-regulated analytical or pharmaceutical environment
• You are competent in a range of analytical methods (HPLC/GC/Dissolution)
• Working knowledge of Empower lab software & electronic document management systems
• Understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions
• You will work as part of a collaborative analytical team, contributing to high-quality data delivery in a fast-paced, GMP-regulated environment
• Opportunity to work on development-stage and commercial products
• Collaborative and quality-driven environment