SENIOR MANAGER, MANUFACTURING SCIENCES PURIFICATION Company Bayer Healthcare LLC Location Berkeley, CA Position Type Full Time Experience See below for details Education See below for details Bayer HealthCare LLC seeks Senior Manager, Manufacturing Sciences Purification for Berkeley, CA.
Responsible for leading team of scientists & engnrs in commercial purification processes & contributing to cGMP mnfctr of licensed product.
Master''s degree or for.
in Chem, Chem Engnrng, or Pharmctcls & 3 yrs of exp as scientist in dvlpmnt/mfg of FDA rgltd products incl.
at least 2 yrs of exp supervising & directing rsrch prjcts in compliance w/FDA regs req''d.
Exp must incl.
wrkng in cGMP mnfctr of licensed prdct; cndctng scale-up from bench (lab) to commercial scale; & prdcng docs to enable prdct mrktng.
Must know thru crswrk or exp:
purification methods (incl.
ion exchng, reverse phase, hydrophobic interaction, precipitation); analytical characterization & structure determ.
chromatography, NMR, IR, x-ray); unit ops dvlpmnt in prcss dsgn; occupatn''l & prcss safety; regulatory req''ts for prdctn of therapeutic proteins; validation req''ts for aseptic products; aseptic mfg; & req''ts for mfg in classified areas (clean rooms).
Apply at www.

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