Lead a high-performing analytical lab team driving cutting-edge bioanalytical CMC testing (ELISA, SPR, cell-based assays) in GMP-regulated drug development. Shape operations, inspire people, and deliver scientific excellence while partnering closely with customers and senior leadership.
- Lead an analytical lab operations team, focusing on providing services incl. ELISA, SPR and Cell-based bioassay testing in the context of CMC analytical drug development
- Personnel management of multiple Analytical Managers, Scientists, Lab Technicians and ensure high-performance team execution
- Define priorities across lab sub-areas, ensuring effective workload distribution
- Oversee laboratory capacity planning, recruitment, and career development
- Promote a culture of collaboration, accountability, and operational excellence
- Ensure budget adherence and cost-efficient operation of laboratories
- Identify opportunities for cost-saving and process optimization
- Act as the primary liaison between the analytical team and senior leadership
- Represent the company in interactions with customers
- Ensure all analytical activities align with health, safety, environmental and GMP/ISO 9001 quality standards
- Drive continuous improvement initiatives to enhance compliance and efficiency
- Lead audit preparations and interactions, CAPA implementations
- Background in CMC bioanalytical drug development testing (ELISA, SPR, Cell-based bioassays) under GMP
- Educational background in biochemistry, analytical sciences or a related field
- Industry experience (>5 years) in biopharmaceutical drug development environment, with a strong background in GMP/ISO-regulated analytical testing
- Proven industry leadership experience
- Expertise in regulatory compliance, analytical method development, and operational excellence
- Demonstrated ability to drive continuous improvement in analytical workflow processes
- High-level problem-solving, conflict resolution, and decision-making skills
- Strong ability to engage with customers
- Strong communication skills
- Fluent in English (additionally German is beneficial)
