MSAT Scientist II

Role Description

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

DUTIES:

• Work on process transfer and process support to provide all functions associated with process transfer and process support including:
• Perform gap analysis
• FMEA
• Generate process models
• Author process descriptions and batch records
• Author change controls
• Perform process monitoring including manufacturing data summary and analysis
• Data presentation
• Author campaign summary reports
• Perform activities for lot release and assess deviations
• Provide guidance on process transfer and support activities to junior members of the team.
• Work on deviations, problem solving, and data analysis to assess all major deviations including those that impact product quality.
• Identify potential root causes using a systematic approach and potential solutions.
• Use a variety of problem-solving tools including Fishbone and Kepner-Tregoe.
• 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.
• Participate in Customer and Regulatory Audits.
• Represent MSAT on project teams and interface with customer technical and quality representatives.
• Ensure employee training profile is up to date at all times by regular monitoring of training lists including Compliance Wire, SAP Learning Portal, and completing all training in a timely fashion.
• Follow all training and policy guidelines established for the facility as well as all cGMP requirements.
• Work on computer skills allowing interface with critical software.
• Perform all types of complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis.
• Act as a support role for a more senior scientist.
• Participate in collecting data for analysis but not expected to perform analysis or interpret data.
• Manage MSAT tasks in program schedule and drive tasks to completion.
• Develop training activities for the MFG area or MSAT department.
• Author process change controls in Trackwise and set due dates appropriately based on scope of work.
• Own change control tasks and drive document updates authored by others.
• Identify, evaluate, and initiate cost saving projects for a specific customer program.
• Develop process understanding.
• Act as a reviewer on existing process documents ensuring changes proposed by more senior scientists are being implemented.
• Observe troubleshooting activities for learning opportunities.
• Work on various software systems including Teams, Word, Excel, Outlook, PowerPoint, Planview, DMS document management system, Statistica, Trackwise, Simca, Global Data Mart, Pi DataLink software, Pi Vision software, Syncade, SAP, Delta V, Power BI, Orchestrate scheduling systems, and various cloud-based data storage systems including SharePoint.
• Work on aseptic technique and mammalian cell culture.
• Demonstrate knowledge of cell culture bioreactors with sufficient acumen to perform troubleshooting on active cultures during processing.
• Understand and interpret statistical models including multivariate analysis presented through Excel, Statistica, Power BI, and similar software.
• Demonstrate proficiency with Statistica, Power BI, Simca, and Pi Vision to remotely monitor processing and prepare technical presentations for customers.
• Perform product impact assessments of highly technical deviations that occur during GMP production through technical writeups in the TrackWise documentation system.

Qualifications

• Master’s degree, or foreign equivalent degree in Chemical and Biochemical Engineering or Biotechnology
• 2 years of experience in the job offered or in a related occupation
• Experience with various software systems including Teams, Word, Excel, Outlook, PowerPoint, Planview, DMS document management system, Statistica, Trackwise, Simca, Global Data Mart, Pi DataLink software, Pi Vision software, Syncade, SAP, Delta V, Power BI, Orchestrate scheduling systems, and various cloud-based data storage systems including SharePoint
• Experience working on aseptic technique and mammalian cell culture
• Demonstrated knowledge of cell culture bioreactors
• Understanding and interpreting of statistical models including multivariate analysis
• Proficiency with Statistica, Power BI, Simca, and Pi Vision

Requirements

• Master’s degree, or foreign equivalent degree in Chemical and Biochemical Engineering or Biotechnology
• 2 years of experience in the job offered or in a related occupation

Benefits

• Opportunity to improve lives around the world
• Engagement in solving complex problems and developing new ideas in life sciences

Company Description

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.