Project Lead QC 80-100%

Reposted 21 Hours Ago
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Stein, Aargau, CHE
In-Office
Senior level
Pharmaceutical
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization.
The Role
Lead QC project execution for release and stability testing of late‑phase and commercial biologics (including ADCs). Coordinate analytical method transfers, assess lab capacity, manage timelines and customer interactions, author GMP quality records, provide scientific guidance on testing strategies, and act as QC SME for audits and regulatory readiness in partnership with program managers and cross‑functional teams.
Summary Generated by Built In

 

The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

As Project Lead Quality Control, you will act as the primary QC contact for customers, assessing laboratory capacity, coordinating analytical method transfers, thereby ensuring the successful implementation of release and stability testing for late-phase and commercial biologics.

Working closely with Program Managers and cross-functional teams, you will drive QC project execution, manage timelines and customer interactions, provide scientific guidance on analytical testing strategies, and ensure regulatory and GMP-compliant delivery of project milestones. Check out Your Career in Drug Product  Services at Lonza!

This role is primarily based on site. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. We offer flexibility to work remotely for no more than 20% of your time. Requests are considered on a case‑by‑case basis, in line with business needs.

What you will get:

  • An agile career and a dynamic work culture.

  • An inclusive and ethical workplace.

  • Compensation programs that recognize high performance.

In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits.

The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits

What you will do:

  • Lead and coordinate QC related project activities for release and stability testing of late-phase (PPQ) and commercial drug products, with a focus on large molecules and Antibody Drug Conjugates (ADCs).

  • Serve as the primary QC representative and project champion, driving project execution through effective coordination of timelines, deliverables, customer engagements, and stakeholder communication in close partnership with Program Managers.

  • Assess laboratory capacity and manage analytical method transfers, ensuring timely implementation of testing to meet customer and project requirements.

  • Implement analytical testing strategies, including method suitability assessments, performance evaluation, control strategies, and specification setting.

  • Author for quality records and cGMP documents e.g. procedures (SOPs) or source documents, reports, deviations, change requests etc.

  • Act as QC subject matter expert during audits, inspections, and customer meetings while ensuring GMP-compliant documentation and regulatory readiness.

What we are looking for:

  • Work experience in a GMP-regulated pharmaceutical Quality Control environment with a sound understanding of analytical testing of biologics (large molecules) is a must.

  • You enjoy working with many different people: strong collaboration and stakeholder management skills, with the confidence to coordinate activities, provide constructive challenge, and interact effectively with customers and internal teams.

  • Experience in project coordination, analytical method validation and/or method transfer is a strong advantage.

  • Fluency in English is a must, fluency in German is a plus.

  • Degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related life sciences discipline.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.

Skills Required

  • Work experience in a GMP-regulated pharmaceutical Quality Control environment with understanding of analytical testing of biologics (large molecules).
  • Degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related life sciences discipline.
  • Fluency in English.
  • Strong collaboration and stakeholder management skills; ability to coordinate activities and interact with customers and internal teams.
  • Ability to author quality records and cGMP documents (SOPs, reports, deviations, change requests).
  • Experience supporting audits, inspections, and regulatory readiness as a QC subject matter expert.
  • Experience in project coordination.
  • Experience in analytical method validation and/or method transfer.
  • Fluency in German.
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The Company
HQ: Basel
Year Founded: 1897

What We Do

At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.

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