Lead Scientist Quality Control

Lead Scientist Quality Control

Lonza

Basel, Switzerland

Key Responsibilities

• Perform routine and validation physico-chemical assays for biologics, following cGMP, SOPs, and Data Integrity standards
• Carry out and review essential lab tasks such as mobile phase preparation and equipment calibration (e.g., pH meters, balances), ensuring accuracy and compliance
• Provide expert mentorship to team members on analytical methods and instrumentation, supporting the Laboratory Manager in resolving technical challenges and improving lab performance
• Serve as a key resource for specific analytical technologies, contributing to process improvements, audit readiness, and representing the lab during inspections
• Proactively investigate and resolve equipment issues, driving root cause analysis and implementing effective corrective actions
• Ensure the lab environment meets cGMP standards through diligent cleaning, inventory management, and adherence to 6S principles
• Participate in and lead initiatives aimed at optimizing laboratory operations and improving analytical workflows
• Support the development and maintenance of analytical infrastructure and on-call (Pikett) services

Key Requirements

• On-the-job training as lab technician (e.g. EFZ, CTA) with BSc/MSc degree and experience in Analytical Chemistry, Biochemistry, or related field
• Highly experienced working in a GMP-regulated QC laboratory, with a strong focus on biologics and advanced analytical techniques
• Proven proficiency in HPLC, CE-SDS, icIEF, and compendial methods; experience with method validation and troubleshooting is essential
• Demonstrated ability to mentor junior staff, lead investigations, and contribute to cross-functional initiatives
• In-depth understanding of cGMP, GDocP, and Data Integrity principles; experience supporting audits and inspections
• Strong analytical thinking and problem-solving skills, with a proactive approach to identifying and resolving technical issues
• Excellent written and verbal communication skills in English; ability to clearly present technical information to diverse audiences
• Dedicated, meticulous, well-organized, and able to manage time and priorities effectively

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