Project Lead Commercial Qc

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 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

  • Qc Manager Cgt

    Vor 7 Tagen

    Stein, Schweiz Novartis Vollzeit

    25000+! The total no. of associates in NTO who deliver high quality, affordable medicines on time, every time, safely and efficiently. We strive to become the top manufacturer of innovative and generic medicines in the industry - while keeping our patients at the heart of everything we do. - Major accountabilities: - Manages laboratory personnel, provides...

  • QA Expert for Qc 80

    vor 1 Tag

    Stein, Schweiz Lonza Vollzeit

    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,...

  • Team Lead Quality Control

    Vor 7 Tagen

    Stein, Schweiz Lonza Vollzeit

    **Location: Stein AG (Switzerland)** Today, Lonza is a global leader in life sciences operating across five 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...

  • Head Quality Control Dps Growth Project

    Vor 5 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...

  • QA Manager

    Vor 5 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...

  • Global Commissioning

    Vor 3 Tagen

    Stein, Schweiz Lonza Vollzeit

    A Career at Lonza **What you’ll get** - An agile career and a dynamic work culture - An inclusive and ethical workplace - Compensation programs that recognize high performance Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific...

  • Lead Scientist Qc Microbiology

    Vor 3 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...

  • Technical Project Manager

    vor 2 Wochen

    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...

  • Electrical Instrumentation Lead

    Vor 7 Tagen

    Stein, Schweiz Universal-Job Vollzeit

    **Beschreibung** Reports to: CAPEX Lead ADC Dolphin / Technical Project Manager -Support and Review of Design Documents related to their Discipline -Leads and Coordinates Sensor Risk Assessment according Project Standards -Ensures Swiss and Project Standards are kept. -Coordination of Operations SMEs, Global SMEs and Design Team -Oversee Deliverables in...

  • QA Manager

    Vor 3 Tagen

    Stein, Schweiz Universal-Job Vollzeit

    In this role, you will support the QA/QC oversight and do QA driven projects on requests. Your accountabilities will include: - Ensure compliance according to internal quality standards, relevant regulatory requirements and the filed product quality standards - Ensure QA monitoring of the allocated products in the QC organization - Manage all quality aspects...