Lonza is currently seeking an experienced MSAT Scientist ll to join their team in Portsmouth, NH.

POSITION: MSAT Scientist II

JOB LOCATION: 101 International Drive, Portsmouth, NH 03801

DUTIES: Perform all functions associated with process transfer and process support, develop process understanding, perform gap analysis / FMEA, generate process models, author / review Process Descriptions and Batch Records, author / review planned deviations and change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, perform activities for lot release (assess deviations and process changes). Provide guidance on process transfer and support activities to junior members of the team. Assess all major deviations including those that impact product quality. Identify potential root causes using a systematic approach. Use a variety of problem-solving tools e.g. Fishbone, Kepner-Tregoe etc. to perform effective root cause analysis. Able to identify potential solutions. Perform or can understand all types of complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis. Authors and reviews process descriptions, definitive formulations, batch records, raw material listings, change controls independently and authors/reviews/modifies the corresponding templates. Assess change controls for impact of any change to the process, equipment or procedures that can affect process performance and product quality. Support documentation preparation for regulatory purposes. Represent MSAT on project teams and interfaces with customer technical and quality representatives. Represent MSAT on internal teams (e.g. Deviation and Run Daily Management System meetings). Participate in Customer and Regulatory Audits. Follow all training and policy guidelines established for the facility as well as all cGMP requirements. Ensure employee training profile is up to date at all times by regular monitoring of training lists (e.g. Compliance Wire, SAP Learning Portal) and completing all training in a timely fashion. Utilize process support, process development, and/or process scale up and manufacturing. Use familiarity with commercial manufacturing, current Good Manufacturing Practices, and US / EU regulations.

MINIMUM REQUIREMENTS: Requires a Bachelor's degree, or foreign equivalent degree in Electronic Engineering, Computer Science, or Chemical Engineering and three (3) years of experience in the job offered or three (3) years of experience in a related occupation utilizing process support, process development, and/or process scale up and manufacturing; using familiarity with commercial manufacturing, current Good Manufacturing Practices, and US / EU regulations.