Brigitte Bomer
Research and Development Program Manager @ICU Medical
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WORK HISTORY
Research and Development Program Manager @ICU Medical
Led qualification program for new Active Pharmaceutical Ingredients (APIs), coordinating with cross-functional teams to ensure compliance with relevant standards and regulations.Submitted to and gained approval from the FDA for 7 new drugs that were commercialised with 20 other qualifications and submissions in progress.Brought back a product facing a national drug shortage affected by supply chain issues related to shortages from COVID-19 vaccine prioritization.Maintained program schedule and managed project timelines, budgets, and resources, ensuring successful completion of qualification activities within budget constraints and approved project plan.Facilitated regulatory audits from the FDA, Health Canada, and other regulatory agencies, with a proven track record of effectively communicating with regulatory auditors and providing strategic support in both the strategy room and ready room during inspections.Coordinated with external partners and vendors as necessary to ensure successful completion of the qualification process.Presented findings and updates to internal stakeholders, including executive leadership, ensuring effective communication of project status and risk management. Drove day-to-day Project Team activities to meet project milestones and keep functions on track in compliance with Corporate and Site policies and procedures. Understood critical path activities and anticipated steps that may be bottlenecks.Organized and facilitated effective meetings. Identified and delegated action items, followed up/tracked action items to resolution, updated project plans & deliverables, as required, identified issues, and ultimately resolved issues off-line (to ensure effective meetings at all levels), with subsequent escalation as required.Demonstrated expertise in leading and managing cross-functional teams to achieve objectives in a highly matrixed environment.
EDUCATION
Texas A&M University
Master of Science (M.S.), Plant Pathology and Microbiology
Texas A&M University
Bachelor of Science (B.S.), Bioenvironmental Science
SKILLS
ABOUT BRIGITTE BOMER
Experienced in Program and project management, Validation, Research, and Manufacturing with a demonstrated history of working in the pharmaceutical and biotechnology industry. Skilled in Terminal sterilization, Sequencing, Targeted Enrichment, RNA bait production, Mutagenesis, Microbial Transformation, Molecular Biology, and Management. Professional with a Master of Science (M.S.) focused in Molecular and Cell Biology from Texas A&M University.
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