About this role
Weitere Berufsbezeichnung: Biologe/-in (Studienberuf); Chemiker/-in (Studienberuf) Stellenbeschreibung: Für unseren Kunden, ein weltweit agierendes Pharmaunternehmen, suchen wir im Rahmen der Arbeitnehmerüberlassung einen Senior Scientist Biological Analytics & Microbiology (m/w/d). Ihre Aufgaben: - In this role, you will develop, assess, and implement analytical and microbiological testing strategies to ensure product quality, product safety, and informed CMC decision-making throughout the development process - By contributing to the scientific direction and providing expert input to CMC subteams, you will ensure the timely delivery of high-quality analytical and microbiological results - You will support the evaluation, validation, and implementation of alternative, innovative, rapid, and automated microbiological methods, including the use of AI-based tools to optimize testing processes and data evaluation - As part of the role, you will lead or contribute to technology, innovation, and continuous improvement projects to strengthen analytical and microbiological capabilities in a GMP-regulated environment - You will assess scientific results, prepare accurate reports and documentation, support regulatory submissions where applicable, and collaborate closely with internal and external partners to ensure scientific alignment and effective knowledge exchange Ihr Profil: - PhD in Biology, Microbiology, Biotechnology, Biochemistry, Chemistry, or a related Life Science discipline, preferably with relevant experience in the pharmaceutical industry, alternatively, a Master’s degree with substantial professional experience in an industrial environment - Strong background in biological drug development, quality control, and microbiological product safety, with experience in preparing or contributing to regulatory documentation - In-depth knowledge of analytical methods (e.g. HPLC-SEC, HPLC-CEX, CGE, CZE, icIEF, potency assays) and microbiological testing methods (e.g. sterility testing, bioburden determination, endotoxin testing) - Solid understanding of working within GMP-regulated environments, ensuring compliance with regulatory standards - Strong analytical and problem-solving abilities, excellent communication and presentation skills, and the ability to effectively collaborate in cross-functional and international teams - Fluent English required, German skills are a plus Sie finden sich in dieser Stellenbeschreibung wieder? Dann freuen wir uns über die Zusendung ihrer aussagekräftigen Bewerbungsunterlagen. Ergänzende Informationen: Anforderungen an den Bewerber: Grundkenntnisse: Regulatory Affairs (Arzneimittelzulassung), Qualifizierung/Validierung (Pharmazie), Qualitätsmanagement Erweiterte Kenntnisse: Dokumentation (technisch), Mikrobiologie, Analyse