Emily Bibak
Senior Director, Analytical R & d @Glaukos Corporation
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WORK HISTORY
Senior Director, Analytical R & d @Glaukos Corporation
EDUCATION
Heidelberg University
Ph.D., Pharmaceutical Sciences
Linköping University
Master's degree, Organic Chemistry
UC Irvine
Executive MBA
SKILLS
ABOUT EMILY BIBAK
Methodical, results-driven professional with substantial experience in leading analytical R&D and QC laboratories in cGMP environments in support of new/abbreviated drug development within the pharmaceutical industry.• Consistently exceeds established goals/objectives through development/validation of advanced analytical methods involving HPLC, GC, and Dissolution; organic synthesis; and structural identification (NMR, MS and FTIR).• Possesses expertise in writing SOPs, batch records, MPSPs, CTD/eCTD drug substance and drug product sections for ANDA submission, protocols, and reports for process development, validation, method transfer and stability projects in accordance with current GMP, FDA, and ICH guidelines. • Thrives within stringent deadlines and budgets and with limited staff. • Identifies top-performing personnel for hire/promotion and trains/develops team members within a collaborative, team-focused environment to maximize performance potential.• Ensures full regulatory compliance regarding cGMP requirements and in ANDA submissions.• Able to effectively troubleshoot technical issues and develop effective solutions.• Experienced in overseeing stability of drug substances/drug products and conducting trending analyses.• Proficient in Microsoft Excel, Microsoft Word, Microsoft Project, Powerpoint, Access, ChemDraw, IsisDraw, WinNMR, TrackWise, Empower 2, Chromeleon, and ChemStation.
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