Laboratory Manager Clinical Quality Control Physico Chemical Analytics
vor 6 Monaten
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Key Responsibilities
Lead and manage a Clinical QC Phys-Chem analytical laboratory including related equipment and supporting infrastructure 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. Responsible to 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. Accountable 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.Key Requirements
MSc or PhD degree in Biochemistry, Pharmaceutics, Chemistry or related field incl. 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 (advantageous) 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 e.g. for visible particles, subvisible particles, color, clarity, pH, water-, surfactant- and protein content, HPLC, CE SDS, icIEF, CCIT 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 is a plus Hands on experience in digital laboratory workflows is a plus (e.g. electronic laboratory notebook, LIMS) Business fluent written and spoken EnglishEvery day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Reference: R61238-
Basel, Basel-Stadt, Schweiz Lonza VollzeitLonza is a global leader in life sciences with operations across three continents. Our success is built on talented individuals working together to devise innovative solutions that improve people's lives.We offer our employees the opportunity to own their careers and contribute to meaningful projects. This involves leading and managing a Clinical QC...
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