Today, Lonza is a global leader in life sciences operating across three 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 Scientist ll to join their team in Portsmouth, NH.
POSITION: MSAT Scientist II
JOB LOCATION: 101 International Drive, Portsmouth, NH 03801
DUTIES: 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.
MINIMUM REQUIREMENTS: Requires a Bachelor’s degree, or foreign equivalent degree in Electronic Engineering, Computer Science, or Chemical Engineering and 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.
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.
Skills Required
- Bachelor's degree in Electronic Engineering, Computer Science, or Chemical Engineering (or foreign equivalent)
- Three (3) years of experience in process support, process development, or process scale up and manufacturing
- Familiarity with commercial manufacturing and US/EU regulations
- Knowledge and application of current Good Manufacturing Practices (cGMP)
- Perform process transfer and process support activities, including development of process understanding and process models
- Perform gap analysis and FMEA
- Author and review Process Descriptions, Definitive Formulations, Batch Records, raw material listings, and related templates
- Author/review planned deviations and change controls and assess impact to process and product quality
- Perform process monitoring, manufacturing data summary, analysis and presentation; author campaign summary reports
- Assess major deviations and identify root causes using systematic problem-solving tools (e.g., Fishbone, Kepner-Tregoe)
- Perform or interpret complex data analyses (multiple linear regression, ANOVA, multivariate analysis)
- Support documentation preparation for regulatory purposes and participate in customer and regulatory audits
- Represent MSAT on project teams and interface with customer technical and quality representatives
- Maintain up-to-date employee training profile and complete required training (e.g., ComplianceWire, SAP Learning Portal)
What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
