Beschreibung

As a Process Manager, you will oversee the downstream processes of biopharmaceuticals, ensuring robust designs and compliance while collaborating with various teams. This role involves troubleshooting, optimizing processes, and engaging directly with customers to enhance product life cycles.

Anforderungen

• •University degree in biotechnology, pharmaceutical engineering, bioprocess engineering, chemical engineering, or comparable scientific/technical field
• •Multiple years of experience in downstream processing using scalable technologies in biopharmaceutical manufacturing
• •Strong and motivating communication skills
• •Team spirit
• •Flexibility
• •High level of initiative
• •Personal responsibility
• •Excellent organizational skills
• •Entrepreneurial mindset
• •Economic and analytical thinking
• •Fluency in English
• •Relevant experience with commercial products CPV will be considered an asset
• •Experience in process performance qualification (PPQ) is desirable
• •Know-how in statistical concepts and software (e.g. JMP) is a plus

Aufgaben

• •Design robust and scalable downstream processes for biopharmaceuticals
• •Define control strategies for commercial manufacturing
• •Set up and perform continued process verification (CPV)
• •Communicate directly with customers in meetings and conference calls
• •Collaborate with colleagues from associated departments
• •Troubleshoot and optimize processes at manufacturing scale
• •Participate in deviations, out-of-specifications, and change management
• •Review and own process descriptions, risk assessments, protocols, and reports
• •Ensure compliance with international technological and regulatory standards
• •Review relevant chapters of CMC dossiers (IND/IMPD and BLA/MAA)
• •Participate in client audits and authority inspections
• •Engage in process optimization and innovation projects
• •Continuously strive for improvement and optimization in all work areas

Tools & Technologien

Benefits