Project Lead Commercial Qc

vor 2 Stunden

Stein, Schweiz Lonza Vollzeit

Switzerland, SteinToday, 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:

- Enable release and stability testing of late phase (PPQ and Commercial) Drug Product, specifically for analytical testing of Antibody Drug Conjugates (ADC's)
- Support of laboratory planning as well as introduction and transfer of Analytical test methods to enable Drug Product release and stability testing
- Represent Lonza in internal and customer meetings as project champion
- Demonstrating knowledge of analytical testing by e.g. compendial and generic methods, HPLC and (i)CE purity methods, content determination, Bio-chemical methods (ELISA, SPR, Cell based potency / binding / activity assays), qPCR, MS, dimension testing.
- Project coordination (timelines and deliverables are visible and maintained in planning tools), in collaboration with Program Manager
- Implementing the testing strategy (evaluation of method performance, suitability, control strategy, specifications setting)
- Maintaining up-to-date knowledge of assigned projects (molecules, formulation, product presentation)
- Author for quality records and cGMP documents e.g. procedures (SOPs) or source documents, reports, deviations, change requests etc.
- Acting as regulatory liaison for QC in collaboration with the Lonza regulatory expert team
- Participate as Subject Matter Expert in internal and external audits, customer visits and inspections
- Supporting draft of proposals and manufacturing contracts (SoWs)
- Driving a lean mindset and establish mechanisms for continuous improvement

Key requirements:

- Relevant experience in pharmaceutical industry, preferred with Academic degree in life sciences, e.g. Analytical Chemistry or Biochemistry
- Excellent working knowledge in relevant analytical techniques related to testing of drug products, specifically Antibody Drug Conjugates.
- Solid knowledge of good manufacturing practices (GMPs) and Profound knowledge in corresponding regulations, qualification/validation, compliance systems (e.g. ICH guidelines, PIC/s, USP, EP, JP, PMDA, EMA)
- Strong analytical and problem-solving skills
- Substantial experience in Quality Control and project management 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: R60543

  • Postgraduate Qc

    vor 1 Woche

    Stein, Schweiz Novartis Vollzeit

    135.000 Novartis Mitarbeitende in 140 Ländern weltweit teilen die Vision eines besseren heute und morgen für Patienten - eine Vision die unser Wachstum und unseren Erfolg antreibt. Die Abteilung Qualitätskontrolle (QC) am Standort Stein unterstützt das Sterilwerk für alle verschiedenen analytischen (physikalischen und chemischen sowie mikrobiologischen)...

  • Project Control Manager

    vor 2 Wochen

    Stein, Aargau, Schweiz Lonza Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

    Lonza is seeking a Project Controls Manager with the relevant experience to support the Global Engineering (GE) Capital Projects for Lonza's new facilities and infrastructure in Stein, Switzerland.The Project Controls Manager will manage and coordinate project control activities including planning, cost control, risk management, change management and...

  • Qc Lab Technician Bioanalytics

    vor 2 Wochen

    Stein, Schweiz Novartis Vollzeit

    769 million! That's how many patients' lives were touched by our products in 2020. At Novartis, we are reimagining medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many...

  • Msat Lead Dps Growth Project

    Vor 6 Tagen

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinToday, 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...

  • Lead Training

    Vor 6 Tagen

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinToday, 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...

  • Project Champion Drug Product Services Growth

    vor 2 Wochen

    Stein, Schweiz Lonza Vollzeit

    Switzerland, Stein 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,...

  • Technical Project Manager

    Vor 2 Tagen

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinToday, 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...

  • Head Manufacturing Compounding and Support Dps

    Vor 6 Tagen

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinToday, 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...

  • Principal Scientist Qc Microbiology

    Vor 6 Tagen

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinToday, 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...

  • Trainee Project Dolphin

    vor 1 Woche

    Stein, Schweiz Lonza Vollzeit

    Switzerland, SteinToday, 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...