Melanie Kross
Senior Scientist, Upstream Clinical Supply at Laureate Biopharmaceutical Services- Claim this Profile
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Bio
Experience
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Laureate Biopharmaceutical Services
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United States
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Biotechnology Research
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1 - 100 Employee
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Senior Scientist, Upstream Clinical Supply
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2007 - Present
Lead Scientist in a group of 6 scientists Tech transfer of Upstream Process from Process Development to Clinical Production. Drafting/revising Master Batch Records Strong client interaction Scale up process from bench scale (12L) to 75L-2500L ABEC Bioreactors and/or 250L or 1000L Hyclone SUBs. Scale up in Shaker Flasks and WAVE Bioreactors up to the WAVE 1000 Pilot and GMP Production Strong vendor interaction Lead Scientist in a group of 6 scientists Tech transfer of Upstream Process from Process Development to Clinical Production. Drafting/revising Master Batch Records Strong client interaction Scale up process from bench scale (12L) to 75L-2500L ABEC Bioreactors and/or 250L or 1000L Hyclone SUBs. Scale up in Shaker Flasks and WAVE Bioreactors up to the WAVE 1000 Pilot and GMP Production Strong vendor interaction
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Centocor
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Biotechnology Research
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400 - 500 Employee
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Manufacturing Associate III
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Jan 2001 - Sep 2007
Commercial manufacture of Remicade. Cell expansion from vial thaw through WAVE Bioreactor. Operation of 110L and 1000L Perfusion Bioreactors and associated media and harvest vessels. Commercial manufacture of Remicade. Cell expansion from vial thaw through WAVE Bioreactor. Operation of 110L and 1000L Perfusion Bioreactors and associated media and harvest vessels.
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The Immune Response Corporation
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Biotechnology Research
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Manufacturing Associate
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1999 - 2001
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Education
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Cedar Crest College
Bachelor of Science, Genetic Engineering