MSAT Scientist ll

Lonza•Portsmouth, NH

6d•Onsite

About The Position

Lonza is currently seeking an experienced MSAT Scientist II to join their team in Portsmouth, NH. This role involves performing all functions associated with process transfer and process support, developing process understanding, performing gap analysis/FMEA, generating process models, and authoring/reviewing various process-related documents. The position also includes process monitoring, data analysis, authoring campaign summary reports, and lot release activities. The MSAT Scientist II will provide guidance to junior team members, assess major deviations, and utilize problem-solving tools for root cause analysis. They will also perform complex data analysis, support documentation for regulatory purposes, and represent MSAT on project and internal teams. Adherence to training and cGMP requirements is essential.

Requirements

Bachelor’s degree, or foreign equivalent degree in Electronic Engineering, Computer Science, or Chemical Engineering
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

Responsibilities

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