Process Chemist

Process Chemist (PR&D) Job Description 

A leading company in the chemical and pharmaceutical sector is seeking to hire a PR&D Chemist. This role is based on-site at a Research and Development Centre in Swords, Co Dublin, which brings together technical and operational expertise to support the development and manufacturing of clinical and commercial products, particularly small molecule Active Pharmaceutical Ingredients (APIs). 

Job Overview: 

The PR&D Chemist will have expertise in synthetic organic chemistry, supporting the development and optimization of both new and existing chemical processes. Key responsibilities include process scale-up, technology transfer, process safety, monitoring, and troubleshooting for small molecules. The role requires cross-functional collaboration with teams such as Operations, Quality, and Safety, as well as external stakeholders, to ensure that chemical processes are well-understood, efficient, robust, and controlled for both existing and new product introductions. 

Key Responsibilities: 

• Lead laboratory-based development projects, including route scouting, route development, proof of concept work, crystallization optimization, and process safety evaluations. 

• Provide technical support for API and intermediate manufacturing processes, with a focus on optimization and investigative activities. 

• Initiate and manage process optimization projects, keeping scalability, manufacturing, and Critical Quality Attributes in mind. 

• Utilize data monitoring and Process Analytical Technology (PAT) tools such as FBRM, Raman, and IR to enhance laboratory processes. Seek and implement new technologies to support the site’s development objectives. 

• Collaborate with R&D analytical chemists and operations engineers on the introduction and scaling up of new products. This includes supporting process development, customer engagement, troubleshooting, documentation, and campaign preparation. 

• Conduct chemistry assessments for new product introductions when required. 

• Lead and collaborate on projects aimed at optimizing throughput and yield, working closely with operations engineers. 

• Support continuous process verification by collecting and analyzing commercial product data, identifying out-of-trend results (OOT) and statistical alert events (SAE), and leading investigations in collaboration with engineers and analytical chemists. 

• Actively contribute to manufacturing campaign performance and support teams. 

• Lead or assist in quality and safety investigations. 

• Ensure compliance with GMP, Quality, and Health & Safety standards in all tasks. 

Minimum Qualifications and Experience: 

• Minimum of three (3) years’ work experience in a GxP pharmaceutical manufacturing environment. Experience in a high-velocity CDMO environment is a plus. 

• A strong technical foundation in chemistry, with a PhD in organic chemistry or equivalent industrial experience in process development. 

Key Skills and Competencies: 

• Excellent interpersonal and communication skills, with proven experience working in a matrix environment. 

• Strong problem-solving abilities and a commitment to continuous improvement. 

• Experience in project management, process troubleshooting, and continuous process verification. 

• Proficiency in using root cause analysis tools and statistical methods. 

• Familiarity with various analytical and diagnostic tools, including PAT, chromatography, and process safety assessments. 

This position offers a unique opportunity to work at the intersection of research, development, and manufacturing, contributing to the successful scale-up and optimization of chemical processes for small molecule APIs.