Qc Sector Head Bioassays

vor 6 Monaten

Basel, Schweiz Lonza Vollzeit

Switzerland, BaselKey responsibilities:

- 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

Key requirements:

- 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

Every 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: R60346

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