Senior Process Development Scientist / Engineer
, Manufacturing Sciences and Technology Group, Lonza Biologics, Portsmouth, NH
This challenging position is available in the
group of the Manufacturing Sciences and Technology Department (MSAT), in our Portsmouth facility.
Lonza Biologics is the world’s leading Contract Manufacturing Company providing development and manufacturing services to the Biopharmaceutical Industry.
· Perform all functions associated with process transfer and scale up to manufacturing e.g. develop process understanding, perform gap analysis / FMEA, generate process models, author / review Process Descriptions and Batch Records, assists in equipment commissioning and validation activities
· Perform all functions associated with process monitoring and lot releases e.g. manufacturing data summary and analysis, data presentation; author campaign summary reports, assess deviations and process changes
· Interface with customer technical and quality representatives, represent MSAT group in Project Teams
· Evaluate proposals from new customers
· Keep current with advances in technology in the fermentation and upstream processing
· Some non-standard work hours e.g. evening or weekend work will be required, up to 10% travel to customer or Lonza sites may be required
Qualifications and Experience
· A Ph.D. in Biological Sciences or Engineering, plus more than 8 years experience in process development, scale up or Manufacturing support in the Biotech industry; B.S. / M.S. with more than 15 years of relevant experience in the Biotech industry
· 5+ years of biotech industry experience in process development or process scale up / manufacturing
· Familiarity with large scale manufacturing, current Good Manufacturing Practices, US / EU regulations
· Advanced knowledge of cell biology, mammalian cell culture, scale up and mass transfer, disc stack centrifugation, filtration, statistical data analysis
· Good communication skills, interpersonal skills, ability to work in a fast paced environment
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