At Lonza, we're a global leader in life sciences, operating across three continents. Our approach is rooted in collaboration and innovation.
Key Responsibilities:
* Lead and manage a Clinical QC Phys-Chem analytical laboratory to ensure 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 in a matrix organization, 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.
* Accountable to deliver QC work packages on time for customer projects and support the laboratory team by e.g. closure of 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 are adhered to by self and own team.
* Ensure safety regulations are followed within the area.
Key Requirements:
* MSc or PhD degree in Biochemistry, Pharmaceutics, Chemistry or related field with solid work experience in 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, digital laboratory workflows and business fluent written and spoken English.