Job Description

YOUR TASKS AND RESPONSIBILITIES

Implement overall production concepts for novel biopharmaceutical processes currently not established at Bayer in a regulated environment

Set up a technology platform for cell and gene therapy that comprises an end-to-end integrated process of modular unit operations including automation and control concepts
Develop implementation strategies for innovative technologies as well as conceptual design studies for biopharmaceutical production processes either in a new or an existing facility, e.g. for the production of therapeutic proteins
Develop a technology platform for cell and gene therapy through

Process technology design for end-to-end processes including automation
Integration of processing units to provide a holistic production concept
Production module design for new technological solutions
Consideration of GMP process requirements in the technology definition
Definition of cleanroom classification and layout design for the production building

Transfer the new technology platform into the production environment
Analyze best practice from other industries and implement them for cell and gene therapy processes
Lead cross-functional teams in (international) technology implementation projects and take over the role as process lead (m/f/d) in investment projects
Contribute to business cases, benchmarking and due diligences for new bioproduction technologies as well as translate business needs into project scopes

WHO YOU ARE

University degree (Master or (preferred) PhD degree) in biotechnology, bioprocess engineering or related fields with long-term working experience in the field of biotechnology incl. several years of leadership experience

Deep knowledge of different pharmaceutical bioprocesses and their unit operations with in-depth expertise in pharmaceutical production processes based on mammalian cell fermentation (USP and/or DSP) and their implementation in a regulated environment
Extensive knowledge of single-use technology
General knowledge about design of pharmaceutical production facilities incl. building layout, cleanroom classification, personnel and material flows
Familiarity with cGMP rules and regulatory agencies requirements (FDA, EMA, etc.)
Long-term experience in leading and coordinating biotech development or production projects with cross-functional teams with solid knowledge of the methods and tools of project management
Strong collaboration, partnering and networking skills with the ability to build on diversity and inclusion
Strong communication skills in English, both verbal and written; German is a plus