Project Lead QC 80-100%

Lonza; Stein; Hybrid; Vertraulich; Vollzeit

Benefits dieser Stelle

Lifestyle benefits

Competitive compensation

Zusammenfassung

Lonza is seeking a Project Lead Quality Control to serve as the primary QC interface for customers, coordinating analytical method transfers and release testing for late‑phase and commercial drug products. The role emphasizes collaboration with Program Managers and cross‑functional teams to ensure GMP‑compliant delivery of milestones.

You will lead QC project execution, manage timelines, and provide scientific guidance on testing strategies while ensuring regulatory readiness and effective

Qualifikationen

• GMP-regulated pharmaceutical QC experience, biologics (large molecules).
• Experience in project coordination and stakeholder management.
• Degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related life sciences discipline.

Aufgaben

• Lead and coordinate QC project activities for release and stability testing of late-phase and commercial drug products, focusing on large molecules/ADCs.
• Serve as the primary QC representative and project champion, coordinating timelines, deliverables, and customer interactions with Program Managers.
• Assess laboratory capacity and manage analytical method transfers to ensure timely testing.
• Implement analytical testing strategies including method suitability assessments and specification setting.
• Author quality records and cGMP documents (SOPs, deviations, change requests).
• Act as QC SME during audits/inspections and customer meetings with regulatory readiness.

Kenntnisse

Stakeholder management

Project coordination

Analytical testing

GMP compliance

English fluency

German language (nice to have)

Ausbildung

Chemistry/Biochemistry/Biology/Pharmaceutical Sciences degree

Jobbeschreibung

Switzerland, Stein

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 serve as the primary QC interface for customers, evaluating laboratory capacity, coordinating analytical method transfers, and ensuring the successful implementation of release and stability testing for late-phase and commercial Drug Products.

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.

Reference: R77596