Key requirements:

• Bachelor’s degree in life sciences or Engineering required
• Substantial GMP (Good Manufacturing Practice) experience in aseptic filling of biologics  or equivalent
• Substantial management experience in a QA supervisory or management role.   
• Working knowledge of cell culture starting materials and aseptic drug product filling experience required.
• Experience with oversight of aseptic filling and the associated international aseptic drug product processing regulations and medical device regulations.
• ASQ Certification (preferred)
• GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing; ISO 9001:2015, 13485 and Part 11 compliance knowledge preferred.
• Working Knowledge of (LAL) endotoxin testing preferred.
• The ability to interface and communicate directly with clients may be required.
• Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
• Strong collaboration and communication skills required. Ability to multitask and adequate sense of urgency a must.

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.