MSAT Process Engineer/Scientist II (Downstream)

Location: On-site, Portsmouth, NH

About the role

The MSAT Process Engineer/Scientist II is responsible for being the primary technical support for mammalian manufacturing processes. This individual has in-depth experience with supporting manufacturing processes and/or technical transfer. The supervisor provides direction and oversight, as this level is expected to have a good grasp of the requirements of the role. The individual is a subject matter expert for key aspects of the role and is expected to raise questions when clarification or greater technical expertise is required.

Responsibilities

• Performs all functions associated with process transfer and process support, including developing process understanding, performing gap analysis/FMEA, generating process models, authoring/reviewing Process Descriptions and Batch Records, authoring/reviewing planned deviations and change controls, performing process monitoring, authoring campaign summary reports, and performing activities for lot release.
• Provides guidance on process transfer and support activities to junior members of the team.
• Assesses all major deviations, including those that impact product quality, and identifies potential root causes using a systematic approach and problem-solving tools (e.g., Fishbone, Kepner-Tregoe).
• Performs or understands complex data analysis such as multiple linear regression analysis, ANOVA, and multivariate analysis.
• Authors and reviews process descriptions, definitive formulations, batch records, raw material listings, and change controls independently, and modifies corresponding templates.
• Assesses change controls for impact on process, equipment, or procedures that can affect process performance and product quality.
• Supports documentation preparation for regulatory purposes.
• Represents MSAT on project teams and interfaces with customer technical and quality representatives.
• Participates in internal teams (e.g., Deviation and Run Daily Management System meetings).
• Participates in Customer and Regulatory Audits.

Requirements

• Bachelor’s degree in Biotechnology, Biological Sciences, or Chemical Engineering.
• 3+ years of biotech industry experience (2+ years with Master’s) in process development and process scale-up/manufacturing.
• Experience with large-scale manufacturing support (mammalian preferred), current Good Manufacturing Practices (cGMP), and US/EU regulations.
• Advanced knowledge of cell biology, cell culture, scale-up and mass transfer, bioreactor operation, disc stack centrifugation, and filtration.
• Intermediate knowledge of statistical data analysis.
• In-depth knowledge of large-scale manufacturing, cGMP, and US/EU regulations.
• 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.
• Access to Lonza’s full list of global benefits.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together to manufacture the medicines of tomorrow. Our core values—Collaboration, Accountability, Excellence, Passion, and Integrity—reflect who we are and how we work. Innovation thrives when people from all backgrounds bring their unique perspectives, and Lonza offers 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.