Head of QC Project Leads / Project Expert 80-100% (m/f/d)

☞ Lonza

View: 131

Update day: 11-04-2024

Location: Basel Basel-Stadt BS

Category: Quality Assurance / Quality Control

Industry: Pharmaceutical Manufacturing

Job type: Full-time

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Job content

Switzerland, BaselToday, 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.For Drug Product Services (DPS) , our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland , we have 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 of (Senior) Project Expert / Team Lead.Key Responsibilities
  • Lead, manage and develop a team of experienced (Senior) Project Leaders within the Development Phys-Chem QC department and report directly to the respective department head
  • Provide successful and compliant (e.g. Lonza SOPs, PIC/S, ICH, 21CFR211) guidance and support to project leaders on general and specific aspects of quality and analytical development challenges
  • Take responsibility and accountability as business processes owner and procedures owner including continuous development and improvement of concepts as required
  • Accountable for the successful definition and implementation of late phase QC development standard stages of work including definition of related capacity planning embedded into Lonza`s overall development concept
  • Manage quality events as required, e.g. deviations, CAPA, change requests
  • Network and liaise effectively with partner units and relevant stakeholders within the Lonza network to contribute to the department`s success and positive perception (internal/external customers)
  • Ensure effective use of resources (time, personnel, equipment, etc.), cGMP and EHS (environment, health and safety) guidelines are followed and continuously evolved as required
  • Lead initiatives to support the growth of Development QC on GMP compliant development of new entities, e.g. bioconjugates, viral vectors and small molecules (liquids)
Minimum Required Qualifications/Skills
  • PhD or MSc in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences or related field
  • Extensive working experience in Analytics or Quality Control of pharmaceuticals is a must, preferably for Biologics and under cGMP regulations
  • Excellent working knowledge in phase appropriate technical development of new drugs from GMP phase initiation till commercial launch (BLA/MAA). Substantial experience in late phase to launch development activities is a must
  • Experience with development QC of drug product bioconjugates and viral vectors in addition to antibodies/proteins is beneficial
  • Proven leadership experience (matrix and leading leaders) including proven track record in leading organizational transformations
  • Highly motivated self-starter with demonstrated skills to persuade key stakeholders both cross-functional and cross-site
  • Fluent in English is a must
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: R52530Apply
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Deadline: 26-05-2024

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