MSAT Scientist ll Full-time

MSAT Scientist II

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

Duties include performing all functions associated with process transfer and process support, 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, data presentation), authoring campaign summary reports, performing activities for lot release (assessing deviations and process changes). Provide guidance on process transfer and support activities to junior team members. 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 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 include 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.