MSAT Process Engineer/Scientist III - Downstream

MSAT Senior Process Engineer/Scientist – Downstream Location: On-site, Portsmouth, NH. Responsibilities Primary technical support for mammalian manufacturing processes, including process transfer and support activities. Develop process understanding, perform gap analysis/FMEA, and generate process models. Author and review Process Descriptions, Batch Records, planned deviations and change controls, and create campaign summary reports. Perform activities for lot release and assess root causes of deviations impacting product quality using systematic problem‑solving tools such as Fishbone and Kepner‑Tregoe. Conduct complex data analysis including multiple linear regression, ANOVA, and multivariate analysis. Assess change controls for impact on process performance and product quality, supporting regulatory documentation preparation. Represent MSAT on project teams and interfaces with customer technical and quality representatives, internal teams, and participate in customer and regulatory audits. Qualifications Bachelor’s degree in Biotechnology, Biological Sciences, or Chemical Engineering. 6+ years of biotech industry experience (2–5 years of Ph.D.) in process development, scale‑up, and manufacturing. Experience supporting large‑scale mammalian manufacturing, Good Manufacturing Practices, and US/EU regulations. Advanced knowledge of cell biology, cell culture, scale‑up, mass transfer, bioreactor operation, disc‑stack centrifugation, filtration, and intermediate statistical data analysis. Willingness to provide 24/7 on‑call support during manufacturing. Benefits Competitive salary and comprehensive benefits package. Opportunities for career development and advancement. Supportive and collaborative team environment. Access to cutting‑edge technology and tools. Commitment to employee well‑being and safety. Inclusive workplace culture. Recognition and reward for contributions. About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. #J-18808-Ljbffr