MSAT Scientist II Full-time NEW

MSAT Scientist II

Lonza is seeking an experienced MSAT Scientist II to join their team in Portsmouth, NH [and various unanticipated locations throughout the U.S.; may work from home].

MSAT Scientist II needed by Lonza Biologics, Inc. to work on process transfer and process support to provide all functions associated with process transfer and process support including 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 including manufacturing data summary and analysis, data presentation, author campaign summary reports, and perform activities for lot release assess deviations and process changes. 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. Able to identify potential solutions. Work on document and change assessments including author and review process descriptions, definitive formulations, batch records, raw material listings, change controls independently, and author reviews and modify 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 interface with customer technical and quality representatives. Represent MSAT on internal teams including 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 including Compliance Wire, SAP Learning Portal, and completing all training in a timely fashion. Work on computer skills allowing interface with critical software. Work on 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. This position is responsible for being the primary technical support person for biopharmaceutical manufacturing processes to support more than three manufacturing processes and performing one process transfer. Will 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 deviations that occur during GMP production through technical writeups in the TrackWise documentation system.

Minimum requirements: Requires a Bachelor degree, or foreign equivalent degree, in Chemical Engineering, Biochemical Engineering, or Biotechnology, and 3 years of experience in the job offered or 3 years of experience in a related occupation working on computer skills allowing interface with critical software; working on 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; working on aseptic technique and mammalian cell culture; demonstrating knowledge of cell culture bioreactors with sufficient acumen to perform troubleshooting on active cultures during processing; understanding and interpreting statistical models including multivariate analysis presented through Excel, Statistica, Power BI, and similar software; demonstrating proficiency with Statistica, Power BI, Simca, and Pi Vision to remotely monitor processing and prepare technical presentations for customers; performing product impact assessments of deviations that occur during GMP production through technical writeups in the TrackWise documentation system.

Alternatively, the employer will accept a Master's, or foreign equivalent degree, in Chemical Engineering, Biochemical Engineering, or Biotechnology, and 2 years of experience in the job offered or 2 years of experience in a related occupation working on computer skills allowing interface with critical software; working on 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; working on aseptic technique and mammalian cell culture; demonstrating knowledge of cell culture bioreactors with sufficient acumen to perform troubleshooting on active cultures during processing; understanding and interpreting statistical models including multivariate analysis presented through Excel, Statistica, Power BI, and similar software; demonstrating proficiency with Statistica, Power BI, Simca, and Pi Vision to remotely monitor processing and prepare technical presentations for customers; performing product impact assessments of deviations that occur during GMP production through technical writeups in the TrackWise documentation system.

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.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

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.