Teamlead (f/m/d) - MSAT / Process Validation
agcbio · Heidelberg, Germany · On-site
Posted Aug 19, 2026
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About AGC Biologics
AGC Biologics is a leading global biopharmaceutical contract development and manufacturing organization (CDMO). Our global network spans three continents, with cGMP-compliant facilities in Denmark, U.S., Italy, Germany, and Japan. We currently employ more than 2500 team members worldwide. We collaborate with some of the world’s leading and most innovative pharmaceutical companies to develop and manufacture life-changing treatments. We are dedicated to bringing products to market that turn possibilities into reality and bring hope to life for patients around the world. To do so, we provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.
Your Mission
We are seeking a passionate and experienced leader to join our Process Development team as the MSAT Team Lead. In this pivotal role, you will be the driving force behind bringing new client projects to life, guiding them from technology transfer to successful GMP manufacturing at our Heidelberg site. You will champion scientific excellence, lead a talented team, and ensure our processes are robust and continuously improved throughout their entire lifecycle.
Your Key Responsibilities
Team Leadership & Development: Lead, mentor, and develop a high-performing team of MSAT specialists. Drive the efficiency, structure, and continuous improvement of the group's operations.
Technology Transfer & Process Introduction: Act as the primary technical lead for transferring complex bioprocesses from clients or other AGC sites. Conduct thorough manufacturability assessments, including process design, facility fit, and risk analysis, to ensure seamless integration.
Process Excellence & Lifecycle Management: Oversee all Process Validation (PV) activities, from planning and execution to final reporting. Champion Continued Process Verification (CPV) and process optimization initiatives, and provide scientific expertise for process characterization studies.
Client & Regulatory Partnership: Serve as a key technical point of contact for our clients, confidently leading communications and supporting on-site visits. You will prepare and support the technical sections of regulatory dossiers and actively participate in health authority audits and inspections.
Cross-Functional Collaboration: Partner with the Business Development team to assess the feasibility of new client proposals. Support GMP manufacturing by leading deviation investigations, providing scientific assessments for change controls, and defining user requirements for new process equipment.
Your Profile
A Master's degree in a relevant scientific discipline with a minimum of 5 years of industry experience, or a PhD with a minimum of 3 years of experience in a cGMP environment.
Extensive leadership experience, with a proven track record of successfully leading and developing…