Senior Scientist ADC Process Development and Manufacturing

vor 3 Wochen

München, Deutschland Tubulis GmbH Vollzeit

As a member of our CMC team, you will support and shape the development of innovative biopharmaceuticals and contribute to overseeing the process development and GMP manufacturing of ADCs. You will work in a highly interdisciplinary environment with the opportunity to learn and adopt new techniques. Your mission Support Process Development and GMP manufacturing of ADCs. Review development reports, master batch records, executed batch records and campaign summary reports. Work closely with Quality Assurance in the review process. Participate in cross-functional project teams and provide regular progress updates during the CMC team meetings. Contribute to assess GMP supply chain and help define production planning. Conduct literature research and prepare conjugation, purification, and analysis plans. Maintaining clear and current documentation, writing SOPs, Risk Assessments and reports. Processing deviations and change controls in close cooperation with Quality Assurance. Participate in or lead continuous improvement projects. Your profile You are highly motivated and independent with excellent communication and interpersonal skills. You feel comfortable effectively working in a dynamic and multidisciplinary team atmosphere. You have either a PhD in biotechnology, chemistry or biochemistry plus a minimum of 3 years of pharmaceutical experience or Masters’ degree plus 5 years of working experience in a pharmaceutical company. Working knowledge of the requirements of GMP manufacturing. Solid understanding of requirements of at-scale manufacturing of drug-substances. Experience of manufacturing drug products (lyophilizates) is a plus. Why us? Flat hierarchies and short decision-making processes; open corporate culture; possibility of mobile working; unlimited contract after probationary period; 30 days' vacation; strong team spirit; personal appreciation of values; multicultural and global team and high level of collegiality; regular team events; mobility allowance; pleasant office atmosphere, modern technology standard. About us The development of novel, effective and safe therapies for the treatment of cancer is one of the main challenges for modern medicine. We want to drive this process forward. The main goal of Tubulis is to become a leading company in the field of targeted therapeutics and antibody-drug conjugates (ADCs). With a strong team, our own technologies and innovative therapeutic concepts, we are ushering in a new era in the ongoing fight against cancer and share the vision of helping patients world-wide. Be part of a multidisciplinary and focused team, that works towards getting novel promising ADCs to patients with solid and hematological cancers.

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