MSAT Process Engineer/Scientist III – Downstream (Biotechnology)

Location: On-site in Portsmouth, New Hampshire, United States

Company

hirify.global operates a globally connected biotechnology manufacturing network focused on producing medicines and life-science products.

What you will do

• Provide primary technical support for mammalian manufacturing processes, including process transfer and process support.
• Develop process understanding, perform gap analyses and FMEA, generate process models, and support process monitoring.
• Author and review process descriptions, definitive formulations, batch records, raw material listings, change controls, planned deviations, and campaign summary reports.
• Assess major deviations, identify potential root causes, and evaluate solutions using structured problem-solving and statistical analysis tools.
• Assess the impact of process, equipment, and procedural changes on process performance and product quality, including preparation of regulatory documentation.
• Represent MSAT on project teams, internal management meetings, customer interactions, and regulatory audits; provide guidance to junior team members.

Requirements

• Bachelor’s degree in Biotechnology, Biological Sciences, or Chemical Engineering.
• 5+ years of biotechnology industry experience, or 3+ years with a master’s degree or 2+ years with a PhD, in process development and process scale-up or manufacturing.
• Experience supporting large-scale manufacturing, preferably mammalian manufacturing, and knowledge of current Good Manufacturing Practices and US/EU regulations.
• Advanced knowledge of cell biology, cell culture, scale-up, mass transfer, bioreactor operation, disc-stack centrifugation, and filtration.
• Intermediate knowledge of statistical data analysis, including regression analysis, ANOVA, and multivariate analysis.
• Willingness to provide 24/7 on-call support during manufacturing.

Culture & Benefits

• Competitive salary and comprehensive benefits package.
• Career development and advancement opportunities.
• Collaborative and inclusive workplace focused on employee well-being and safety.
• Access to advanced technology and tools.
• Recognition and rewards for contributions.