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.
Responsibilities
* Lead an analytical lab operations team, focusing on providing services including 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
Qualifications
* 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)
#J-18808-Ljbffr