Lonza · 4 hours ago
MSAT Senior Scientist
Portsmouth, NH
Full-time
Hybrid
Senior Level
5+ years expLonza is a global leader in life sciences operating across five continents. They are seeking an experienced MSAT Senior Scientist to perform process transfer and support functions, including developing process understanding and conducting complex data analysis. The role involves guiding junior team members and ensuring compliance with regulatory standards.
BiotechnologyLife SciencePharmaceutical
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
Qualification
Required
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 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; 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
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 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; 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
Company
Lonza
Lonza Group supplies products and services to pharmaceutical and agrochemical industries.
10001+ employees
H1B Sponsorship
Lonza has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2022 (1)
2021 (3)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$444.8M2023-11-06Post Ipo Debt· $444.8M
2020-12-07IPO
Leadership Team
Wolfgang Wienand
Chief Executive Officer
Alfons Ehinger
Founder
Recent News
2026-01-07
2026-01-05
Company data provided by crunchbase