Oorspronkelijke vacature omschrijving:

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Our Lonza Global CGT Team is seeking an Associate Director, Global MSAT Process Champion. This individual will be responsible for defining the strategy and the operational execution in collaboration with the CGT sites for New Product Introduction standards with specific focus on all technical topics related to Processing aspects, Process Performance Qualification and Process Validation. Support PD, clinical and commercial operations across all CGT sites, assets and modalities (allogeneic, autologous, exosomes, viral vector). Leads strategic Innovation and Technology Council projects (ITC) as defined and in collaboration with sites and Group Operations. The position provides flex support to augment site technical capabilities and to drive delivery.

Key responsibilities:

• Lead Process Performance Qualification (PPQ), Process Validation (PV), Continuous Process Verification (CPV), Container Closure Integrity Testing (CCIT), Leachable and Extractable (L&E), Visual Inspection (VI), Statistical/Global Data Mart (GDM), and aseptic DP filling standardization across CGT allowing for clear, compliant and prompt decision making and risk mitigation.
• New Product Introduction (NPI) Process Lifecycle Support: Govern CGT GROUP NPI and Process Lifecycle procedures. Collaborate w/ assets to ensure use and understanding and areas for continuous improvement. As assigned, provide flex SME support to assets including all functions associated with process transfer and process support.
• Lead Process & PPQ standardization and harmonization across the CGT Network. Our standardization and continual improvement areas include adoption of Lean Business Management System and cover the following: Materials, Manufacturing Process & PPQ, Training, Sterility Assurance, and Facility & Equipment.
• Assess documentation, processes, and programs for continuous improvement, error reduction, and increased operator aseptic and process knowledge and skill.
• Manage transfer of non-standard or complex processes to cGMP Manufacturing.
• Provide sterility assurance expertise on APS design, investigations, and new product introductions/tech transfers to meet global and regulatory requirements from an early stage.

Key requirements:

• Bachelor’s Degree required in a field of study such as Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, or other life science degree with 10-15 years’ experience within the bio/pharma industry or Master’s Degree with 5-10 years’ experience.
• Experience with New Product Introduction and Process Lifecycle standards (Performance Qualification (PPQ), Process Validation (PV), Continuous Process Verification (CPV), Container Closure Integrity Testing (CCIT), Leachable and Extractable (L&E), and Visual Inspection (VI),
• Drug Product (DP) and Sterility Assurance (material quality attributes, aseptic interventions, Aseptic Process Validation, facility and equipment, Grade A / B allowances and restrictions)
• Root Cause Investigation, FMEA, gap assessments
• People management and training methods
• Database and spreadsheet creation and maintenance
• Statistical (or other equivalent advanced analytics software)
• Organization, Record keeping, and Planning skills
• Managing multiple projects, Time management
• This position is remote with up to 20% travel (domestic and international).

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.