Global MSAT Drug Product Qualification and Validation Lead

Global MSAT Drug Product Qualification and Validation Lead

Lonza

Stein, Switzerland

What you’ll do:

• Serve as global process owner for DP manufacturing process control strategy including equipment qualification (PQ), process validation (PPQ), and continued process verification (CPV) for liquid (vial/PFS/Cartridges) as well as lyophilized dosage forms for biological products;
• Lead the development and governance of corresponding global SOPs, Standards, Templates, and Tools aligned with regulatory and industry best practices;
• Own the equipment qualification (PQ) strategy for key unit operations e.g. DS thawing, compounding, filling, lyophilization, and crimping;
• Support customer products throughout the 3 phases of process validation (process design, PPQ and CPV) by providing guidance and oversight to Tech Transfer and local MSAT teams for optimum justification of product specific validation strategies (PPQ and CPV) including scale up activities and statistical support e.g. sampling plan justification;
• As required, review and approve process validation documentation; conduct statistical analysis on production data for each phase of process validation;
• Active participation in health authority inspections as SME for process validation and CPV/OPV strategy, as applicable;
• Implement Process Capability/Quality/Cost Improvement Changes;
• Enable innovation and technical strategy projects associated to DP aseptic manufacturing.

What we’re looking for:

• Ph.D. in pharmaceutical sciences, pharmaceutical engineering, biochemistry, or related fields or similar qualification;
• 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 (lyophilized products, liquid in vials and PFS) including proven experience with regulatory submission with HAs and PAI;
• Profound understanding of statistics, statistical analysis in support to equipment qualification, process validation and continuous process verification. Applied Statistical Data Science certification or lean black belt certification required; experience with SAA JMP / STATISTICA software is highly desirable;
• In depth knowledge of risk assessments, deviation and change management, root cause investigation analysis;
• Excellent writing skills and documentation practices;
• Excellent communication skills and command of English both written and oral;
• Excellent leadership and interpersonal skills; proven ability as team player and ability to manage cross-functional teams;
• Excellent planning and organizing skills.