MSAT Scientist II

Location: Onsite at 101 International Drive, Portsmouth, NH 03801, United States

Company

hirify.global is a global life sciences company providing products and services for biopharmaceutical and healthcare applications.

What you will do

• Perform process transfer, process support, process development, and process scale-up activities.
• Develop process understanding, generate process models, and conduct gap analyses and FMEA.
• Author and review process descriptions, definitive formulations, batch records, raw material listings, change controls, planned deviations, and campaign summary reports.
• Monitor manufacturing processes through data summaries, analysis, and presentations, and support lot release assessments.
• Investigate major deviations, identify root causes using systematic problem-solving tools, and evaluate potential solutions.
• Represent MSAT on project, deviation management, customer, quality, and regulatory teams, including customer and regulatory audits.

Requirements

• Bachelor’s degree or foreign equivalent in Electronic Engineering, Computer Science, Chemical Engineering, or a related field.
• At least three years of experience in the offered role or a related occupation.
• Experience with process support, process development, process scale-up, and manufacturing.
• Familiarity with commercial manufacturing, current Good Manufacturing Practices, and US/EU regulations.
• Ability to perform or understand multiple linear regression, ANOVA, multivariate analysis, and other complex data analyses.
• Ability to work onsite at the Portsmouth, New Hampshire facility.

Culture & Benefits

• Work in life sciences on products and services that improve people’s lives.
• Collaborate with scientific, technical, quality, customer, and regulatory stakeholders.
• Follow facility training, policy, ethical, environmental, and cGMP standards.
• Maintain an up-to-date training profile and complete required training through systems such as Compliance Wire and SAP Learning Portal.