QC Sector Head Bioassays
Lonza
- Basel
- Unbefristet
- Vollzeit
- Establishment of infrastructure and services in frame of project ramp-up for commercial finished drug product Bioassay testing.
- Support of analytical method transfer and/or validation of bioanalytical assays (cell based Bioassay)
- Provide expertise and ensure adequate cGMP QC lab processes for cell based Bioassays
- Ensure laboratory and workforce planning in order to manage expected forecast
- Author for bioassay / bioanalytical related quality and cGMP documents e.g. procedures (SOPs) or source documents, reports, deviations, change requests etc.
- Developing an effective and cohesive teamwork, fostering close collaboration with internal and external customers and stakeholders
- Ensuring an inspection readiness state for the site to meet expectations from customers and regulators
- Participate as Subject Matter Expert in internal and external audits, customer visits and inspections
- Oversee and manage departmental performance and quality metrics
- Driving a lean mindset and establish mechanisms for continuous improvement
- Relevant experience in pharmaceutical industry, preferred with Academic degree, e.g. PhD in Cell biology, Molecular biology, Biochemistry, or e.g. Analytical Chemistry
- Excellent working knowledge in relevant analytical techniques related to testing of biological drug products
- Knowledge of pharmaceutical regulatory landscape (cGMP, ICH guidelines and pharmacopeias e.g. USP, EP, JP)
- Strong analytical and problem-solving skills
- Substantial experience in Quality Control in pharmaceutical industries and cGMP controlled environment
- Ability to effectively prioritize and direct tasks in a fast-paced environment
- Excellent communication skills, command of English, academic writing