MSAT Scientist ll

United States, Portsmouth (New Hampshire) – Lonza is a global leader in life sciences. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. We let our people own their careers, and their ideas genuinely improve the world.

About the role

Lonza is seeking an experienced MSAT Scientist II to join their team in Portsmouth, NH. This role involves process transfer, process support, and ensuring compliance with cGMP and regulatory requirements.

Responsibilities

• Perform all functions associated with process transfer and process support, including developing process understanding and performing gap analysis/FMEA.
• Generate process models, author/review Process Descriptions, Batch Records, planned deviations, and change controls.
• Perform process monitoring, including manufacturing data summary, analysis, and presentation.
• Author campaign summary reports and perform activities for lot release, including assessing deviations and process changes.
• Provide guidance on process transfer and support activities to junior team members.
• Assess major deviations impacting product quality and identify potential root causes using systematic approaches (e.g., Fishbone, Kepner-Tregoe).
• Perform complex data analysis, including multiple linear regression, ANOVA, and multivariate analysis.
• Author and review process descriptions, definitive formulations, batch records, raw material listings, and change controls.
• Assess change controls for impact on process performance and product quality.
• Support documentation preparation for regulatory purposes.
• Represent MSAT on project teams and interface with customer technical and quality representatives.
• Participate in internal teams (e.g., Deviation and Run Daily Management System meetings) and Customer/Regulatory Audits.
• Ensure compliance with all training, policy guidelines, and cGMP requirements.
• Maintain an up-to-date employee training profile by monitoring and completing training in a timely fashion.
• Utilize experience with commercial manufacturing, cGMP, and US/EU regulations.

Requirements

• Bachelor’s degree (or foreign equivalent) in Electronic Engineering, Computer Science, or Chemical Engineering.
• Three (3) years of experience in process support, process development, and/or process scale-up and manufacturing.
• Familiarity with commercial manufacturing, current Good Manufacturing Practices (cGMP), and US/EU regulations.