Group Head Analytical Development and Quality Control

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Pharma Technical Development Europe Biologics brings game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative and effective drugs using cutting edge technologies for manufacturing process (Drug Substance and Drug Product), clinical supply, analytics, formulation, device and packaging. Our daily work includes authoring of regulatory documents and the transfer of development projects to the commercial organization. We are striving for a caring and sensing network organization which lives a culture of trust and collaboration. Our people drive innovation through their expertise, passion and "getting it done" mentality. The benefit for the patient is in the centre of our thoughts and efforts. The department Analytical Development and Quality Control Biotech Europe is responsible for Biochemical and Biophysical Analytical Development, Quality Control and Compliance for Biopharmaceuticals from pre Investigational New Drug (IND) to New Drug Application (NDA) and Launch. We are seeking a Group Head Analytical Development and QC to join our team on a 2 year fixed term contract. You will lead a team of scientists and be an expert in protein analytics and characterization. The Opportunity - Evaluation, implementation, and further development of new technologies/ test methods to ensure state of the art analytics - Analytical validation and transfer of methods - Representation of Analytical Development and Quality Control in global technical development teams including the coordination of all necessary analytical activities for biotechnological development products - Quality control for investigational medicinal products and batches used in preclinical and clinical studies - Setting of specifications and shelf life for investigational medicinal products and support of IND and BLA (Biologics License Application) filings - Creation of prerequisites for securing a competent, efficient GxP conform analytics in due time and keeping the current GxP guidelines as well as the relevant SOPs - Direct leadership responsibility for a team of approx. 4-6 members - Establish close and trustful collaborations and relationships Who you are - Technical background: You have a PhD in Analytics, Biochemistry, Pharmacy or similar scientific qualification in addition to 3-5 years experience in biopharmaceutical industry with focus on protein analytics and characterization, preferably in a GMP environment. Expertise with techniques such as HPLC, capillary electrophoresis is needed. ID testing experience is a plus. - Experience in development of new technologies and methods for biophysical/biochemical analysis and characterization of proteins is essential in this position - People Leadership: Proven track record in people management and collaboration. You demonstrate a strong background in developing people and ensuring a high performance culture - Excellent verbal and written communication skills with success in building trustful relationships. Self-motivated, pro-active, responsible, result-oriented and an excellent team player. Excellent communication and negotiation skills in German and English If you are an experienced scientist passionate about protein analytics, we would love to hear from you. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.