Global MSAT Drug Product Qualification and Validation Lead(m/w/x)

In this role, you will oversee the drug product manufacturing process, ensuring compliance and quality through equipment qualification and process validation. Your expertise will guide teams in optimizing validation strategies and implementing improvements in aseptic manufacturing.

Anforderungen

• •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
• •Profound understanding of statistics and statistical analysis in support to equipment qualification and process validation
• •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