MSAT Senior Scientist

Lonza•Portsmouth, NH

23h

About The Position

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Lonza is currently seeking an experienced MSAT Senior Scientist to join their team in Portsmouth, NH. POSITION: MSAT Senior Scientist JOB LOCATION: 101 International Dr. Portsmouth, NH 03801 [and various unanticipated locations throughout the U.S.; may work from home] MSAT Senior Scientist needed by Lonza Biologics Inc. in Portsmouth, NH [and various unanticipated locations throughout the U.S.; may work from home] to perform all functions associated with process transfer and process support including developing process understanding, performing gap analysis/FMEA, generating process models, authoring/reviewing Process Descriptions and Batch Records, authoring/reviewing planned deviations and change controls, performing process monitoring (manufacturing data summary and analysis and data presentation), authoring campaign summary reports, and performing activities for lot release (assess deviations and process changes). Recommend improvements for MSAT practices and procedures. Provide guidance on process transfer and support activities to junior members of the team. Assess all major deviations including those that impact product quality as well as post lot release deviations that may impact multiple products. Identify potential Root causes using a systematic approach. Apply knowledge in use/application of variety of problem-solving tools including Fishbone, Kepner-Tregoe, etc. Identify potential solutions and lead multidisciplinary teams in developing and implementing solutions. Perform, understand, and interpret all types of complex data analysis including multiple linear regression analysis, ANOVA, and multivariate analysis and identify applications where appropriate. Authors and reviews process descriptions, definitive formulations, batch records, raw material listings, change controls independently and authors/reviews/modifies the corresponding templates. Identify and create new documents that would aid in process transfer or support activities. Identify process changes and assess change controls for impact of process/equipment or procedural changes that can affect both 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 including Deviation and Run Daily Management System meetings. Participate in Customer and Regulatory Audits. Interact with site leadership on matters concerning several functional areas, divisions, and/or customers. 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 and SAP Learning Portal and complete all training in a timely fashion. Perform other duties as assigned. 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. 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 within a process by requiring investigation to identify potential impacts and data to be reviewed to determine impact to process.

Requirements

Requires a Bachelor degree, or foreign equivalent degree, in Biological Sciences, Biomedical Engineering, Chemical Engineering, or Biotechnology and Bioinformatics and 9 years of progressive, post-baccalaureate experience in the job offered, or 9 years of progressive, post-baccalaureate 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, or any other equivalent data analysis and monitoring tools and software (Spotfire or JMP), as well as quality management programs (CDOCS or Veeva Vault); utilizing 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 interpretating 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; and performing product impact assessments of deviations within a process by requiring investigation to identify potential impacts and data to be to determine impact to process.
Alternatively, the employer will accept a Master degree, or foreign equivalent degree, in Biological Sciences, Biomedical Engineering, Chemical Engineering, or Biotechnology and Bioinformatics, and 5 years of experience in the job offered or 5 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, or any other equivalent data analysis and monitoring tools and software (Spotfire or JMP), as well as quality management programs (CDOCS or Veeva Vault); utilizing 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 interpretating 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; and performing product impact assessments of deviations within a process by requiring investigation to identify potential impacts and data to be reviewed to determine impact to process.

Responsibilities

Perform all functions associated with process transfer and process support including developing process understanding, performing gap analysis/FMEA, generating process models, authoring/reviewing Process Descriptions and Batch Records, authoring/reviewing planned deviations and change controls, performing process monitoring (manufacturing data summary and analysis and data presentation), authoring campaign summary reports, and performing activities for lot release (assess deviations and process changes).
Recommend improvements for MSAT practices and procedures.
Provide guidance on process transfer and support activities to junior members of the team.
Assess all major deviations including those that impact product quality as well as post lot release deviations that may impact multiple products.
Identify potential Root causes using a systematic approach.
Apply knowledge in use/application of variety of problem-solving tools including Fishbone, Kepner-Tregoe, etc.
Identify potential solutions and lead multidisciplinary teams in developing and implementing solutions.
Perform, understand, and interpret all types of complex data analysis including multiple linear regression analysis, ANOVA, and multivariate analysis and identify applications where appropriate.
Authors and reviews process descriptions, definitive formulations, batch records, raw material listings, change controls independently and authors/reviews/modifies the corresponding templates.
Identify and create new documents that would aid in process transfer or support activities.
Identify process changes and assess change controls for impact of process/equipment or procedural changes that can affect both 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 including Deviation and Run Daily Management System meetings.
Participate in Customer and Regulatory Audits.
Interact with site leadership on matters concerning several functional areas, divisions, and/or customers.
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 and SAP Learning Portal and complete all training in a timely fashion.
Perform other duties as assigned.
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.
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 within a process by requiring investigation to identify potential impacts and data to be reviewed to determine impact to process.