Job Detail

Analytical Operations and QC Lab Manager - BDC

Inseriert am: 26.02.2021

A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


An exciting new opportunity has arisen at our State-Of-The-Art Biotech Development Facility in Switzerland.


Analytical Operations and QC Lab Manager - BDC


The Biotech Development Center (BDC) is our Company's next flagship biotech investment in line with the ambition to stay the Vibrant Science and Technology Company. The BDC is integrating analytical technologies of the future with high-tech automatized and digital laboratories, in a flexible, agile and highly collaborative environment.


 


Your role:


In the “Analytical Operations & Quality Control” organization of Global Analytical Development, this role represents an opportunity to significantly contribute to the startup of high-tech GMP analytical laboratories in the BDC, and will give you direct management responsibility over a team of analytical experts and technicians involved in both early phase GMP and non-GMP CMC analytical activities. You will be responsible to provide reliable analytical support through innovation, expertise, and collaboration, enabling timely and scientifically informed decision making to ensure the delivery of our specialty innovator Biotech pipeline to patients.


 


Your key responsibilities in this role are:



  • Manage the startup of high-tech GMP analytical laboratories in the BDC and related documentation; oversee analytical equipment qualification processes and services

  • Lead the Analytical Operations and Quality Control Physico-chemical Lab to conduct early phase GMP and non-GMP testing, leveraging on organizational and operational flexibility in the BDC

  • Target the lab focus on Safety, Quality, Service, Efficiency, People as well as on automated and digital technologies

  • Responsible for method implementation, qualification, for early phase programs and testing continuity for the managed laboratory; responsible for laboratory planning, coordination and performance monitoring

  • Provide analytical competence and technology, so that all analytical activities comply with the BDC Quality Management System and meet regulatory expectations

  • Interact and collaborate with all the other CMC functions and sites in the technical development team for the assigned projects

  • Interact with auditors in the context of internal audits and external inspections by HAs

  • Raise and manage any risk/issues on critical path to CMC development team and analytical technical functions, and propose continuous improvement for processes and technologies

  • Manage, develop, coordinate and engage laboratory staff, including training program, performance management, and development plans


 


Who you are:



  • Graduate degree or Ph.D in Chemistry, Pharmacy, Biology, or Biotechnology with an emphasis on Protein Analytical Chemistry

  • 5+ years hands-on experience in physico-chemical methods, with 2+ years previous laboratory management experience and knowledge of GLP/GMP/Quality Systems requirements and international guidelines (e.g. ICH)

  • Knowledge of Data generation, Data processing, Data Quality principles

  • Hands-on experience with laboratory information systems, digital tools, automation technologies and lean principles

  • Curiosity and open minded to new tools & technology, with change management mindset to influence team future ways of working

  • Communication skills to inspire and motivate team / relationship management, with ability to interact in stakeholder networks, with proven collaborative attitude

  • Leadership skills with people development orientation; problem solving, focus on delivery

  • English fluent, French is a plus


What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!


Curious? Apply and find more information at jobs.vibrantm.com

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