Senior Analytical Chemist — GMP Method Development

CREGG; Munster; On-site; EUR 65,000 - 90,000; Full time

Job summary

CREGG is seeking a Senior Analytical Chemistry Scientist to join a leading Medical Device company in Galway. The role focuses on analytical method development, validation, and method transfer within a GMP environment.

The ideal candidate has a strong background in HPLC, FTIR, UV, GC, and KF coulometry, with experience in regulatory guidance (FDA/EMA/ICH) and cGMP/cGLP practices. Excellent communication skills are essential for cross-functional collaboration.

Qualifications

• MS in Analytical Chemistry or a science degree.
• 4+ years experience in HPLC, FTIR, UV and wet chemistry.
• Experience with GC, USP App-4 & KF coulometry preferred.
• Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance.
• Test method validation – method transfer desirable.
• Excellent communication skills, both verbal and written.

Responsibilities

• Perform assigned work as agreed with the project lead and/or Analytical Development Manager.
• Maintain laboratory areas, ensuring procedures are complied with to meet regulatory GMP and safety requirements.
• GC – Dissolution testing.
• Development and qualification of analytical methods applicable for API encapsulated in Polymeric Beads.
• Test method validation – method transfer.
• Develop / improve and/or validate robust analytical methods that are GMP friendly based on quality-by-design and document formal protocols and reports.
• Participate in method transfer activities, including writing protocols and reports.

Skills

Communication skills

Regulatory understanding

Method development

Education

MS in Analytical Chemistry

Science degree

Tools

HPLC

FTIR

UV

GC

KF coulometry

Job description

CREGG is seeking a Senior Analytical Chemistry Scientist to join a leading Medical Device company in Galway. The role focuses on analytical method development, validation, and method transfer within a GMP environment.

The ideal candidate has a strong background in HPLC, FTIR, UV, GC, and KF coulometry, with experience in regulatory guidance (FDA/EMA/ICH) and cGMP/cGLP practices. Excellent communication skills are essential for cross-functional collaboration.