Product Test and Raw Material Lead

WuXi BiologicsWuppertal

Stellenbeschreibung:

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.

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