Analytical Development Specialist

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas. Job Description: We are looking for an Analytical Development Specialist to support analytical activities within a GMP-regulated pharmaceutical development environment. The stability technician will be responsible for performing analytical tests on trial, validation, and clinical batches, supporting stability studies, and ensuring compliance with pharmacopeial and ICH standards. Responsibilities: Perform analytical testing of pharmaceutical development batches (e.g., trial, validation, clinical batches) using validated methods. Execute stability studies according to ICH guidelines and internal protocols. Interpret and document analytical results; escalate deviations or abnormal trends. Support investigations related to out-of-specification (OOS) results and other analytical issues. Contribute to the drafting and review of analytical methods, protocols, and reports. Operate and maintain laboratory instrumentation, particularly HPLC systems running on Empower 3. Work in collaboration with Quality Control, Analytical Development, and Quality Assurance teams. Qualifications: Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or a related scientific field (equivalent to 3–5 years of higher education). Experience in a GMP-compliant analytical laboratory (internships or apprenticeships also considered). Strong technical skills in HPLC; experience with dissolution testing is a plus. Proficient in Empower 3 chromatography data software. Solid understanding of pharmacopeias (e.g., Ph. Eur., USP) and ICH guidelines, especially Q1A(R2). Flexibility to work variable schedules Proficient in English (spoken and written); French reading and listening required, speaking/writing is an advantage. Next Steps Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback is negative, we will contact you to halt the recruitment process. Working at PQE Group As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.

Location: Bourgoin-Jallieu, FR

Posted Date: 6/1/2025