Beschreibung

In this role, you will lead a dynamic team focused on process validation for mammalian manufacturing. Your day-to-day responsibilities will include managing validation activities, collaborating with cross-functional teams, and ensuring compliance with regulatory standards.

Anforderungen

• •Bachelor’s, Master’s or PhD degree in biotechnology, chemical engineering or related disciplines
• •Proven leadership experience in managing technical teams and complex projects
• •Minimum 5 years of experience in process validation within a cGMP-regulated biopharmaceutical environment
• •Working experience in biopharma manufacturing and/or process development preferable in Mammalian Manufacturing
• •Strong understanding of GMP
• •Excellent communication, technical writing, and stakeholder management skills
• •Fluency in English

Aufgaben

• •Lead and manage the process validation team
• •Create a supportive and growth-oriented team environment
• •Oversee resource allocation, goal setting, and performance evaluations
• •Plan, execute, and document validation protocols and reports
• •Ensure compliance with regulatory expectations (FDA, EMA, ICH)
• •Manage technical risks associated with process validation
• •Collaborate with MSAT leaders and cross-functional teams
• •Communicate critical process and technical information
• •Oversee validation data for protocol acceptance criteria
• •Conduct statistical analysis for CPV reporting
• •Represent the company in customer meetings, audits, and inspections
• •Compile assessments of change requests and validation deviations
• •Review CMC sections in filing documents and validation reports
• •Drive continuous improvement initiatives
• •Support the development of standardized procedures for compliance