- 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
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QA Operations Head
vor 2 Wochen
Novartis Basel, SchweizWhy join ? DS Bioproduction Basel is an API Launch Site at the interface between Development and Commercial, producing clinical and commercial biological Drug Substance, cell banks and is the Center of Excellence for Bioassay Testing. · The QA Operations Head position involves le ...
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Director, External Quality Control
vor 1 Woche
Moderna Therapeutics Basel, Schweiz**The Role**: · Moderna is seeking an AD/D External Quality Control based in Basal, Switzerland to oversee Quality Control (QC) testing including in-process, release, and stability in support of contract manufacturing and testing facilities and overall international operations fo ...
QC Sector Head Bioassays - Basel, Schweiz - Lonza
Beschreibung
Located in our successful CDMO Business Unit currently offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as QC Sector Head Bioassays for a new sterile Drug product facility to support quality control and manufacturing related project activities.
Key responsibilities:
Key requirements:
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.
