Lab Manager Biochemistry Analytical Dev
In the 'Analytical Development and Innovation' organization, this role presents an opportunity to significantly contribute to the establishment of high-tech analytical laboratories. You will have direct management responsibility over a team of analytical experts and technicians involved in the development and automation of analytical methods, ensuring the delivery of our specialty innovator Biotech pipeline to patients.
Your key responsibilities in this role are:
1. Manage the high-tech analytical development laboratories and related documentation; oversee analytical processes and support the scientific strategy.
2. Lead the 'Analytical Development and Innovation' biochemistry lab to conduct early phase development and automation of analytical methods and ensure high throughput support to process development of NBEs and ADCs.
3. Manage, develop, coordinate, and engage laboratory staff, including training programs, performance management, and development plans.
Skill Requirements
• A graduate degree or Ph.D. in Chemistry, Pharmacy, Biology, or Biotechnology with an emphasis on Protein Analytical Chemistry.
• 5+ years of hands-on experience in but not limited to biochemistry methods (e.g., Immunoassay, Optical density, digital PCR, Capillary Electrophoresis), with 2+ years of previous laboratory management experience.
• Good understanding of USP and DSP processes in the frame of biopharmaceutical development.
• Knowledge on international guidelines (e.g., ICH) for biopharmaceuticals; knowledge of Data generation, Data processing, Data Quality principles, Quality by Design (e.g., DoE).