Job Title: Laboratory Manager Clinical Quality Control Physico Chemical Analytics
About Us
Lonza is a global leader in life sciences, operating across three continents. We work in science, and our greatest scientific solution is talented people working together to devise ideas that help businesses improve lives.
Key Responsibilities
* Lead and manage a Clinical QC Phys-Chem analytical laboratory, ensuring GMP compliant analytical testing of drug entities in different clinical development phases up to market authorization readiness and continuous audit and inspection readiness.
* Maintain QC oversight of activities conducted within own team or cross teams, dependent on process ownership, QC related deliverables, and proactive risk and issue management.
* Lead, manage, and continuously develop a team of laboratory analysts/scientists supported by an effective feedback culture.
* Deliver QC work packages on time for customer projects and support the laboratory team by closing SST failure assessments or OOX events.
* Act as process owner of assigned business processes, e.g., laboratory equipment or SOPs, to continuously improve and maintain compliance and act as subject matter expert in regulatory inspections and customer audits.
* Ensure Key Quality Indicators and other quality metrics like quality records are adhered to by self and own team.
* Ensure safety regulations are followed within the area.
Requirements
* MSc or PhD degree in Biochemistry, Pharmaceutics, Chemistry, or related field with solid work experience in a relevant area.
* Advanced working experience as a laboratory manager, preferably within a cGMP regulated area in the pharmaceutical or chemical industry, in analytical quality control (QC) or Analytical Development of large molecule analytics.
* Proven track record to successfully lead and develop a team of scientists/laboratory analysts.
* Technical knowledge on instruments used within Biologics QC and advanced scientific knowledge of phys-chem analytics performed in the GMP environment.
* Hands-on experience in management of quality records like deviations, CAPAs, Change Requests.
* Proactive self-starter with strong focus on quality, agility on changing priorities, and high level of resilience when coordinating multiple tasks simultaneously.
* Experience with LEAN/6S, e.g., KanBan, and digital laboratory workflows, e.g., electronic laboratory notebook, LIMS.
* Business fluent written and spoken English.