Date: 05-Nov-2015
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Process Development Scientist
Job Responsibilities:
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
Qualifications
Qualifications:
Bachelor of Science degree in Biological Sciences plus 8 years’ biotech industry experience (Master of Science degree in Biological Science plus 5 years’ 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, disc stack centrifugation, filtration, statistical data analysis
Good communication skills, interpersonal skills, ability to work in a fast paced environment
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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/