Principal Analytical Chemist

About the Role

Our client seeks a highly experienced and innovative Principal Analytical Chemist to lead critical analytical development activities for their pharmaceutical pipeline in Belfast . This role is essential for ensuring the quality, safety, and efficacy of our drug products through the development and validation of robust analytical methods. You will play a key role in troubleshooting complex analytical challenges, guiding method transfer, and contributing to regulatory submissions. The successful candidate will possess deep expertise in various analytical techniques and a strong understanding of pharmaceutical quality control and regulatory compliance.

Key Responsibilities

• Lead the development, validation, and implementation of analytical methods for raw materials, in-process controls, and finished drug products.
• Oversee the investigation of out-of-specification (OOS) results and ensure thorough root cause analysis and corrective/preventive actions (CAPA).
• Provide expert technical guidance and mentorship to junior analytical chemists and technicians.
• Author and review analytical sections of regulatory submissions (e.g., IND, NDA, MAA).
• Manage the transfer of analytical methods to contract manufacturing organizations (CMOs) and internal QC labs.
• Collaborate with formulation, process development, and quality assurance teams to support product lifecycle management.

Requirements

• Ph.D. in Analytical Chemistry, Organic Chemistry, or a related field.
• 10+ years of progressive experience in pharmaceutical analytical development and quality control.
• Extensive hands-on experience with a wide range of analytical techniques, including HPLC, GC, MS, NMR, KF, and dissolution apparatus.
• Strong understanding of ICH guidelines, GMP requirements, and regulatory expectations for analytical testing.
• Demonstrated ability to lead projects, mentor staff, and solve complex analytical problems.
• Excellent communication and interpersonal skills, with the ability to present technical information to diverse audiences.

Benefits

• Competitive salary and bonus structure.
• Comprehensive health and wellness benefits package.
• Opportunity to shape the analytical strategy for innovative pharmaceutical products.
• Generous pension scheme and life insurance.
• Hybrid working model supporting work-life balance in Belfast .
• Access to state-of-the-art analytical instrumentation.