Senior Analytical Scientist (Chromatography)
hace 4 días
Montpellier
MedinCell® is a fast-growing pharmaceutical company developing innovative long-acting injectable therapies based on its proprietary BEPO® technology. Our mission is to improve and protect the health of people worldwide while ensuring fair value sharing with our employees—each of whom becomes a shareholder shortly after joining. With a diverse team representing more than 27 nationalities, we foster a highly collaborative and international work environment. We are looking for a Senior Analytical Scientist – Chromatography to join our Analytical Development & Testing team in Montpellier. In this role, you will play a key part in supporting the development of innovative therapies by designing and delivering robust analytical methods. You will contribute directly to project success by ensuring high-quality, reliable data to support development and regulatory activities. Key Responsibilities Design and develop robust chromatographic methods (HPLC/U • PLC)Apply Quality-by-Design (QbD) principles and risk-based approaches, • Perform method development, pre-validation, and transfer activities, • Analyze, interpret, and present scientific data to support decision-making, • Prepare, review, and update SOPs and analytical documents, • Collaborate with cross-functional teams (R&D, Regulatory, Process Development, Project Management), • Interact with external partners, including CDMOs, and support method transfer, • Participate in client meetings and technical discussions in English, • Contribute to continuous improvement initiatives and implementation of best practices, • Identify and evaluate new analytical technologies to expand capabilities Require ments Must have • MSc in Analytical Chemistry, Chemistry, or a related field, • Minimum 5 years of experience in HPLC/UPLC method development and pre-validation in an R&D environment, • Strong experience with Empower3 software, • Solid knowledge of analytical method development principles, • Experience working in a GMP/GLP environment and knowledge of ICH guidelines, • Good written and verbal communication skills in English Nice-to have • Experience with Design of Experiments (DoE) tools (e.g., Fusion QbD or equivalent), • Knowledge of QbD principles applied to analytical methods, • Experience with mass spectrometry (MS) or other analytical techniques, • Experience in an international environment Knowledge, Skills & AbilitiesScientific / Technical • Strong expertise in analytical method development and chromatographic techniques, • Good knowledge of analytical instrumentation and troubleshooting, • Understanding of statistics and experimental design Soft skills • Strong problem-solving and decision-making abilities, • Excellent planning and organizational skills, • Ability to work autonomously and collaboratively, • Adaptability in a fast-paced and evolving environment, • Strong interpersonal and communication skills, • Continuous improvement mindset What We Offer • Opportunity to work on innovative long-acting therapies with global impact, • Employee shareholding program, • Collaborative and international work environment, • Exposure to cross-functional and high-impact projects, • Career development and growth opportunities, • Competitive compensation and benefits package