MSAT Associate Principal Process Lead
United States, Portsmouth (New Hampshire)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
Lonza in Portsmouth, NH is looking for an Associate Principal Process Lead to join our Manufacturing Science and Technology (MSAT) team. As our Associate Principal Process Lead, you will play a crucial role in supporting current and future production of biopharmaceutical processes and facilities, by assisting in new facility design and incorporation of new equipment and technology. Relying on your advanced experience in bioprocessing, you will use your problem solving skills to resolve complex process issues and assess the impact on product. You will also be working with the Engineering group and contribute engineering solutions to processing problems when appropriate. The role also assists with securing future business for Lonza by assessing process fit in Portsmouth assets based upon proposal requests from potential customers.
- Assesses all major deviations including those that impact product quality as well as post lot release deviations that may impact multiple products.
- Identifies potential root causes using a systematic approach. Expertise in use / application of variety of problem solving tools (e.g. Fishbone, Kepner-Tregoe etc.).
- Resolves complex problems and leads multidisciplinary teams in developing and implementing solutions.
- Understand and interpret all types of complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis and identify applications where appropriate.
- Assess process fit into Portsmouth assets from information provided by potential customers as part of the Request for Proposal (RFP) process. Assessments should provide an estimate of time in suite and a general understanding of raw material consumption.
- Manage a portfolio of products at various product lifecycle stages from process transfer through commercialization.
- Management oversight of a team of cell culture and purification subject matter experts providing scientific and technical process support.
- Interact with Lonza clients as technical process lead.
- Bachelor of Science degree in Biological Sciences, or Biomedical/Chemical Engineering.
- Extensive experience in biotech industry in process development, process scale up, tech transfer and manufacturing.
- Extensive working experience with cell culture with working experience in mammalian preferred.
- Extensive experience with large or small scale (2 KL + experience a plus) manufacturing support (mammalian preferred), cGMP and US / EU regulations.
- Substantial knowledge of cell biology, protein structure, scale up, bioreactor operations, centrifugation, depth filtration and intermediate knowledge of statistical data analysis.
- Significant experience working in a customer service oriented role with strong attention to detail and excellent time management skills.
- Strong communication skills that are accustomed to working in a fast-paced environment.
- Strong ability to trouble-shoot complex investigations/issues within process.
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.