Lonza
Biotechnology
MSATSeniorProcessEngineer/ScientistDownstream
“MSAT Senior Process Engineer/Scientist - Downstream at Lonza. Skills: process transfer, process support, mammalian manufacturing, Good Manufacturing Practices. Perform process transfer and support. Develop process understanding”
Industry & Context.
process understanding; gap analysis; FMEA; process models; process monitoring; major deviations; root causes; multiple linear regression analysis; ANOVA; multivariate analysis
Willingness to provide 24/7 on-call support during manufacturing
What They're Looking For.
Must Have
Bachelor’s degree in Biotechnology, Biological Sciences, or Chemical Engineering, 6+ years of biotech industry experience in process development and process scale up / manufacturing, Experience with large scale manufacturing support (mammalian preferred), current Good Manufacturing Practices, US / EU regulations, Advanced knowledge of cell biology, cell culture, scale up and mass transfer, bioreactor operation, disc stack centrifugation, filtration, intermediate knowledge of statistical data analysis, In depth knowledge of large scale manufacturing, current Good Manufacturing Practices, US/EU regulations
Nice to Have
2 to 5 years for Ph. D. in process development and process scale up / manufacturing
What You'll Do.
Perform process transfer and support
Develop process understanding
Generate process models
Author Process Descriptions
Review Process Descriptions
Author planned deviations
Review planned deviations
Author change controls
Review change controls
Perform process monitoring
Author campaign summary reports
Perform lot release activities
Assess major deviations
Identify potential root causes
Author process descriptions
Review process descriptions
Author definitive formulations
Review definitive formulations
Author raw material listings
Review raw material listings
Author change controls
Review change controls
Assess change controls
Support documentation preparation
Represent MSAT on project teams
Interface with customer representatives
Represent MSAT on internal teams
Participate in audits
How You'll Work.
Team & Collaboration
Provide guidance to junior team members; Represent MSAT on project teams; Interface with customer technical and quality representatives; Represent MSAT on internal teams; Participate in Deviation meetings; Participate in Run Daily Management System meetings; Participate in Customer Audits; Participate in Regulatory Audits
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