Product Test and Raw Material Lead

WuXi Biologics; Wuppertal; On-site; EUR 70,000 - 120,000; Full time

Job summary

WuXi Biologics in Germany is seeking a Lead for Product Testing and Raw Materials QC to support MFG19 ramp-up and future GMP operations. You will oversee core QC testing, material qualification, manufacturing readiness and product testing requirements.

The role focuses on building compliant, efficient testing capability, leading a lean team, ensuring GMP compliance, data integrity and quality system adherence, and coordinating with QA, SCM, Manufacturing, MSAT and engineering.

Qualifications

• Bachelor’s or Master’s degree in a chemical/biological field required.
• Experience in QC/GMP laboratory operations in pharma/biopharma.
• Knowledge of GMP, Data Integrity and pharmacopeial requirements.
• People management or project coordination experience preferred.

Responsibilities

• Lead and manage the Product Testing and Raw Material team in Germany QC.
• Oversee product testing readiness, routine testing, and method lifecycle activities.
• Coordinate raw material sampling/testing, qualification and release QC activities.
• Ensure compliance with GMP, data integrity and internal quality systems.
• Lead deviations, investigations, CAPAs and change controls as assigned.
• Maintain GMP/technical documents and ensure training for staff.

Skills

Cross-functional coordination

Communication

Problem solving

Leadership

Resource planning

Quality systems

Education

Bachelor’s or Master’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Biotechnology, Analytical Chemistry or related scientific discipline

Job description

• Lead Product Testing and Raw Material related QC activities at Germany QC during MFG19 ramp-up and future GMP operations.
• Provide clear oversight of core QC testing operations supporting material qualification, manufacturing readiness and product testing requirements.
• Build compliant, efficient and sustainable testing capability while maintaining a lean transitional organization structure appropriate for the current team size.
• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Biotechnology, Analytical Chemistry or related scientific discipline.
• Experience in QC/GMP laboratory operations, pharmaceutical or biopharmaceutical testing environment.
• Experience with product testing, compendial/analytical methods, raw material control, method transfer/verification/validation and GMP documentation is preferred.
• Prior people management, project coordination or acting lead experience is preferred.
• Good understanding of GMP, Data Integrity, pharmacopeial expectations and internal quality system requirements.
• Knowledge of QC testing operations, raw material control, laboratory readiness and investigation/CAPA processes.
• Strong communication, prioritization, problem-solving and cross-functional coordination skills.
• Ability to work effectively in a ramp-up environment with evolving scope and priorities.
• Lead and manage the Product Testing and Raw Material team, including daily coordination, prioritization and resource planning.
• Oversee product-related testing readiness, routine testing execution and method lifecycle activities within the defined Germany QC scope.
• Oversee raw material sampling/testing support, material qualification and release-related QC activities within the defined site scope.
• Ensure all activities are performed in compliance with GMP, Data Integrity, safety, pharmacopeial and internal requirements.
• Lead or support deviations, OOS/OOT, laboratory investigations, CAPAs and change controls related to the assigned area.
• Author, review and maintain relevant SOPs, AMPs, protocols, reports and other GMP/technical documents.
• Ensure equipment, reagents, reference standards, consumables and laboratory tools are appropriately managed for the assigned scope.
• Ensure team members receive required GMP, safety and on-the-job training for initial and ongoing qualification.
• Act as primary QC interface for Product Testing and Raw Material topics with QA, SCM, Manufacturing, MSAT, Engineering and other stakeholders.
• Support audits/inspections, recruitment, onboarding, capability development and continuous improvement within the assigned area.