Product Test and Raw Material Lead

Teil II Primäres Ziel der Stelle / Part II Primary Job Objective

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.

Teil III Mindestanforderungen an die Stelle / Part III Minimum Requirements

Bildungshintergrund und Erfahrung / Education Background and Experience

Bachelors or Masters 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.

Besondere Kenntnisse / Special Knowledge

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.

Teil IV Berufliche Verantwortung / Part IV Job Responsibilities

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.