Job Overview
The role of Global Lead for MSAT Drug Product Qualification is a critical position that involves overseeing the global process control strategy for DP manufacturing, including equipment qualification, process validation, and continued process verification.
This position requires a strong technical background in pharmaceutical sciences or related fields, with extensive experience in equipment qualification, process validation, and statistical analysis.
Key Responsibilities
* Serve as the global process owner for DP manufacturing process control strategy, ensuring compliance with regulatory and industry best practices.
* Develop and govern corresponding global SOPs, standards, templates, and tools aligned with industry standards.
* Own the equipment qualification strategy for key unit operations, such as DS thawing, compounding, filling, lyophilization, and crimping.
* Provide guidance and oversight to tech transfer and local MSAT teams during customer product support throughout the three phases of process validation.
* Review and approve process validation documentation, conduct statistical analysis on production data, and participate in health authority inspections as SME for process validation and CPV/OPV strategy.
* Implement process capability, quality, and cost improvement changes, while enabling innovation and technical strategy projects associated with DP aseptic manufacturing.
Requirements
* Ph.D. in pharmaceutical sciences, pharmaceutical engineering, biochemistry, or related fields.
* Proven experience and technical knowledge of equipment qualification related to aseptic drug product manufacturing processes.
* Extensive experience and technical knowledge of process validation and current validation approaches for sterile manufacturing of biological drug products.
* Profound understanding of statistics, statistical analysis, and risk assessments.
* Excellent writing skills, documentation practices, communication skills, leadership skills, and planning skills.