YOUR TASKS AND RESPONSIBILITIES

Bayer's founding site in Wuppertal, Germany, is expanding its process development capacities in the field of cell and gene therapy. For our new laboratory, we are looking for a laboratory head (m/f/d) for cell and gene therapy process development, who will play a central leadership role in our team for the development of cell culture processes. This excellent opportunity allows for existing cell culture process knowledge and talented leadership skills to be expanded and deepened, while contributing to the development of a new class of medicines for patients. In collaboration with external partners, the candidate (m/f/d) will strengthen and extend his/her professional experience in the area of process development of cell and gene therapies. Cooperation with a highly motivated and renowned team of scientists and engineers promises an exciting and appealing working environment.

• Establish a cell and gene therapy upstream development laboratory and provide technical expertise in the field of process development incl. bioreactor scale-up
• Lead a team of bioprocess development scientists, engineers and technicians
• Implement robust scale-up & differentiation processes in the department of Cell Culture Process Development, in particular for cell & gene therapeutic projects (neuronal, cardiac, NK, T, hiPSC, CHO, HEK, HeLa and other CGT relevant cells) and in collaboration with external partners
• Coordinate and collaborate with neighboring functions on resources and projects
• Be responsible for project management and participate in strategic decisions of the department
• Closely cooperate with the department's laboratory heads to agree on common team values and goals and to implement them during times of change to constantly adapt to new circumstances
• Prepare, review and approve standard operating procedures (SOPs), batch records and other process documentation for cell and gene therapy processes
• Prepare documentation for regulatory submissions and the relevant CMC sections for marketing applications for new drugs
   

WHO YOU ARE

• PhD in (molecular) biotechnology, bioprocess engineering, chemical engineering, life sciences or comparable, with several years of professional experience in the field of cell and gene therapy process development or equivalent experience in startups/ in the pharmaceutical industry
• Multiple years of leadership experience, ideally in a rapidly changing and challenging working environment
• Proven know-how in the development of bioprocesses for the production of bio-therapeutics as well as a wide range of experience in the field of bioprocess development of mammalian cell cultures and in particular in upstream process development with neuronal, cardiac, NK, T, hiPSC, CHO, HEK, HeLa and other cells relevant for cell and gene therapy
• In-depth understanding of experimental design (DoE) and data processing as well as of operational practices (GxP) and process requirements for the development of cell and gene therapy products
• Experience in the preparation of CMC sections for regulatory submissions for biotechnological drugs
• Proven ability to structure, plan and execute complex projects in a fast-paced environment
• Excellent organizational and problem-solving skills with proven ability to apply them across teams, and implement efficient operational processes
• Fluent in German and English, both written and spoken