Our Downstream Development team plays a crucial role in the late-phase development and transfer of biopharmaceutical drug substance (DS) processes. We are contributing significantly to bringing innovative biopharmaceutical drugs to the market and are dedicated to leveraging data science and digital initiatives to drive innovation and efficiency. We are currently seeking a highly skilled and motivated Senior Expert to join our dynamic DSP Development team. In this role, you will be responsible for leading our portfolio pipeline projects in downstream process development. Your expertise will be crucial in supporting our development and submission initiatives, ensuring that our development strategies are aligned with our business goals.
Major Accountabilities
Lead and organize the downstream process development activities for our portfolio pipeline projects
Perform chromatography steps,
cross flow filtration / tangential flow filtration and other membrane separation methods for purification of recombinant proteins as part of process development and characterization at laboratory and pilot scale
Independently plan, organize, perform and document scientific experiments; handle several activities at a time
Documentation of the studies in electronic documentation systems according to defined standards
Evaluate and interpret results, propose and actively support the design of next experiments supervise project related activities; perform complex tasks without having established procedures of downstream processes.
Work according to appropriate standards for quality, ethics, health, safety, environment protection, and information security, lead initiatives to ensure continuous improvement; all activities have to be aligned with organizational workflows and procedures
Generate scientific documents to hand over to internal and / or external partners and support generation of international registration documents under