Senior MSAT Process Engineer/Scientist – Downstream (On-site)

Lonza Group; Portsmouth, Northern (NH, KY); Hybrid; USD 110,000 - 180,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Career development

Collaborative team

Cutting-edge technology

Well-being & safety

Inclusive culture

Recognition rewards

Job summary

Lonza is seeking an MSAT Process Engineer/Scientist III – Downstream in Portsmouth, NH to provide primary technical support for mammalian manufacturing processes. The role involves process transfer, data analysis, and authoring critical manufacturing documents.

A strong background in GMP and process development is essential. You will join a collaborative MSAT team, contribute to regulatory documentation, and support 24/7 on-call manufacturing activities.

Qualifications

• Bachelor’s degree in Biotechnology, Biological Sciences, or Chemical Engineering.
• 5+ years of biotech industry experience (3+ years with Master’s, 2+ years with PhD) in process development and process scale up/manufacturing.
• Experience with large-scale mammalian manufacturing support and GMP, US/EU regulations.

Responsibilities

• Perform process transfer and provide technical support for mammalian manufacturing processes.
• Develop process understanding, conduct gap analysis/FMEA, generate process models, and author/review process descriptions and batch records.
• Author/review planned deviations and change controls; perform process monitoring and campaign summary reports; support lot release.

Skills

Mammalian manufacturing

Process transfer

Data analysis

Root cause analysis

Batch records

Process validation

Education

Bachelor’s degree in Biotechnology/Biology/Chemical Engineering

Tools

Fishbone

Kepner-Tregoe

Job description

Lonza is seeking an MSAT Process Engineer/Scientist III – Downstream in Portsmouth, NH to provide primary technical support for mammalian manufacturing processes. The role involves process transfer, data analysis, and authoring critical manufacturing documents.

A strong background in GMP and process development is essential. You will join a collaborative MSAT team, contribute to regulatory documentation, and support 24/7 on-call manufacturing activities.