Analytical Project Leader

Analytical Project Leader – Small Molecule / Drug Development / Method Validation / cGMP / HPLC/UPLC / ICH-compliant / Regulatory Documentation / English The Analytical Research & Development department is a key part of Synthetic Molecules Technical Development. It is globally responsible for advancing analytical methodologies, performing in-depth analyses of active pharmaceutical ingredients, and diverse dosage forms, as well as preparing detailed regulatory documentation for submission to health authorities. In this role, you will join a motivated and experienced team of analytical scientists. You will lead the analytical development of synthetic molecule projects involving small molecules, from early development to commercialization. This role offers a unique opportunity to apply your expertise in a dynamic, fast-paced environment and contribute to the development of life-changing medicines. The perfect candidate for this Analytical Project Leader role is a highly experienced chemist with a Ph.D. or Master’s degree and a minimum of three years in small molecule drug development. They must be an expert in HPLC/UPLC and ICH-compliant method validation, capable of independently managing stability studies, impurity profiling, and regulatory documentation (IND/NDA). Beyond technical prowess, they are a proactive leader who seamlessly coordinates between internal labs and external partners while maintaining a strict cGMP and quality-focused mindset. As an Analytical Project leader, your main responsibilities will include: * Developing a phase-appropriate control strategy for drug substances and drug products. * Collaborating effectively with stakeholders across various departments. * Coordinating comprehensive analytical activities, which involves generating physical and chemical data for materials, developing/improving and validating analytical test methods or other analytical controls and ensuring thorough documentation, timely delivery and adherence to quality standards * Coaching technicians and junior scientists on project work and serving as a central point of contact for project-related information * Conduct work in compliance with cGMP where applicable, safety, and regulatory requirements. * Supervise internal laboratory activities and / or testing activities at CLOs/CDMOs * Plan and document experiments/results independently and prepare for regulatory submissions such as IND and NDA. * We are seeking a highly skilled and experienced Analytical Chemist with a strong background in small molecule analysis. The ideal candidate will possess: * A Master’s or Ph.D. in chemistry, pharmacy, or a related field, with at least three years of professional experience in analytical development of drug substances or drug products for small molecules * In-depth knowledge of chemistry, including synthesis, purification, and characterization * Expertise in key analytical techniques such as High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC) * Proven experience in developing and validating ICH-compliant analytical methods * Proficiency in degradation and stability studies for small molecules, including forced degradation and impurity profiling * Understanding of key requirements for drug substances and drug product specifications * Excellent command of the English language * A strong quality mindset and excellent attention to detail * Digital savviness to support digital transformation initiatives; familiarity with statistical analysis of analytical data is also advantageous * Open-minded, goal-oriented, and able to work in a fast-developing environment * Takes challenges as opportunities and is able to respectfully collaborate with team members, customers and stakeholders, even in stressful situations * Proficiency in German Reference Nr.: 924934 If this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs[at]itcag[dot]com. Contact us for more information about our company, our positions, or our attractive payroll-only program: +41 41 760 77 01. ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services.