Senior Director Quality Assurance
Nektar Therapeutics is a biopharmaceutical company developing a pipeline of drug candidates that utilize its PEGylation and advanced polymer conjugate technology platforms, which are designed to improve the benefits of drugs for patients. The Companys product pipeline is comprised of drug candidates across a number of therapeutic areas including oncology, pain, anti-infectives, anti-viral and immunology. Nektars research and development activities involve small molecule drugs, peptides and other potential biologic drug candidates. It creates its drug candidates by using its chemistry platform to modify the chemical structure of drugs using polymer conjugates. Nektars drug candidates are designed to improve the pharmacokinetics, pharmacodynamics, half-life, bioavailability, metabolism or distribution of drugs and improve the overall benefits and use of a drug for the patient.
MANAGEMENT PROFILE FOCUSED, QUALITY-DRIVEN MANAGER WITH 15+ YEARS OF EXPERIENCE IN QUALITY ENGINEERING (QE) AND AUDITING WITHIN DIVERSE MANUFACTURING ENVIRONMENTS. HIGHLY SKILLED AT PLANNING AND CONDUCTING AUDITS TO ISO 13485, FDA 210, 211, 820 AND DEVELOPING METHODOLOGIES TO ENSURE ADHERENCE TO GOOD MANUFACTURING PROCESSES (GMP). PROVEN ABILITY TO BUILD AND LEAD TEAMS OF ENGINEERS AND TECHNICIANS. HISTORY OF BUILDING PRODUCTIVE RELATIONSHIPS WITH MANUFACTURERS, EMPLOYEES AND MANAGEMENT FROM DIVERSE BACKGROUNDS. EXPERT TECHNOLOGIST, WITH EXPERTISE IN THE DESIGN, ASSEMBLY, IMPLEMENTATION AND SUPPORT OF SOPHISTICATED TOOLS AND PROCESSES. CORE COMPETENCIES Global Regulatory and Quality Compliance Audits Risk Assessment BiocompatibilityDesign verification\validation Document Control NCR Lean Manufacturing CAPAProcess Improvement Training & Support Specialties: basic, business intelligence, development, engineering, FCA, functional, ISO, leadership, new product development, optimization, process engineering, project management, quality, quality control, radio, risk management, sigma, six sigma, validation,
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