Process Chemist II

Design and optimise chemical processes for the synthesis of new compounds or the production of existing compounds on a large scale. Conduct laboratory-scale experiments to assess the feasibility of new processes and scale them up for production Analyse existing production methods and recommend improvements through the application of chemistry, process engineering, and Lean Six Sigma methodologies. Lead laboratory and pilot plant trials, designing and executing safe and efficient scale-relevant experiments (including Design of Experiments, reaction optimisation, workup design, and product characterisation). Collaborate with engineering and production teams to scale up processes. Troubleshoot process-related issues and develop solutions enhancing yield, quality, or efficiency. Support the scale-up and validation of new or modified chemical processes from lab to plant, ensuring robust transfer and implementation. Assist in implementing in-process analytical techniques (PAT), methods, and procedures to strengthen process control. Provide day-to-day technical support to Manufacturing Operations, assisting with troubleshooting, process deviations, and leading root cause investigations. Author and update Standard Operating Procedures (SOPs), batch documentation, and technical reports; support operator training on new or modified processes. Lead statistical analysis and monitor process data to ensure control and continuous improvement (e.g., monthly trending, batch release data). Maintain accurate records of experiments and results and prepare technical reports. Define and justify critical process parameters (CPPs) to support regulatory filings and process robustness. Troubleshoot process-related issues and develop solutions. Bachelor's degree (Level 8 or higher) in Chemistry, Pharmaceutical Science, Chemical Engineering, or related discipline. 2-3 years' experience in a GMP-regulated environment as a Process, Manufacturing, or Development Chemist. Strong background in synthetic and process chemistry, particularly in route development and optimisation. Strong analytical and troubleshooting skills. Ability to manage multiple projects and meet deadlines. Knowledge of chemical reaction mechanisms and kinetics. Familiarity with laboratory techniques and safety protocols. Demonstrated ability to solve complex chemical and process issues using data-driven approaches. Hands-on experience in scale-up, technology transfer, and pilot plant operations. Excellent technical writing, communication, and presentation skills. Knowledge of cGMP, regulatory expectations, and quality system compliance.