Danielle Buck Email & Phone Number

Peoria, Az, Us

Tucson, Az, Us

Switzerland 🇨🇭 , Ch

-Responsible for all end-to-end Operations Quality product disposition activities and related processes including IRM, change management, and related data analytics.-Provide leadership and guidance to staff directing Quality functions, manage performance and development of direct reports to ensure achievement of organizational, and departmental goals and a productive environment.-Accountable for the quality of the products manufactured and for ensuring compliance with valid specifications and regulatory requirements, Health Authority regulations, Notified Body requirements, Company standards and expectations and support inspection readiness to ensure successful outcomes.-Lead, coach, and guide the organization. Manage performance and development of the members of the Quality Unit to achieve organizational goals and employee personal and professional growth in accordance to Servant-Leadership principles.-Visionary and catalyst leader who is ready to collaborate with our operations and manufacturing sites to deliver high quality products to customers and patients, ensures our right to operate.-Develop and communicate organizational strategies, which ensure the GMP compliance of the site, continuous improvements and achievement of long-term goals.-Partners with functional leaders and teams from Global Operations to develop strategies and set priorities in order to realize business ambitions and create value through leveraging analytics, process excellence, Lean Manufacturing and continual improvement efforts.

Switzerland 🇨🇭 , Ch

-Partners with manufacturing sites and department stakeholders to understand and utilize best practices in support of new acquisition quality integration projects.-Holds lead role for Purchasing and Supplier Controls in notified body and customer inspections in the front room which has resulted in zero audit findings.-Submitted process improvement requests within EtQ to align the SCAR excel from to the SCAR template in EtQ and to the Agile SCAR form. This ensured our QMS meets requirements in order to maintain Roche’s right to operate.-Welcomes development opportunities as exemplified through the SBPA- strategic business partner academy (2019-2020) and leadership mentors.-Comprehensive understanding of quality principles and knowledge of cGMP regulations demonstrated through completion of GMP, GDP, ISO 13485, and ISO 13485 Lead Auditor Training.

Switzerland 🇨🇭 , Ch

-Used the scientific method to troubleshoot operations product failures by collecting, analyzing, and summarizing information and trends. Establishes solid corrective actions to prevent future failures.-Managed multiple critical issues across life cycle teams simultaneously and prioritizes work with key stakeholders as necessary.-Provided manufacturing decision-making information by calculating production, labor, and material costs, reviewing production schedules, and estimating future requirements.-Supported production with technical assistance to formulation and quality control associates.-Utilized daily MRP/ERP System experience (SAP/ PRISM) for inventory management, EtQ reliance (electronic batch record system), and Agile PDM (document management software) for daily support tasks.-Initiated, executed, and documented validation activities (IQ, OQ, and PQ).-Experienced with tissue based assays (IHC/ISH/H&E) and analytical methods (pH, spectrophotometry, gel electrophoresis, quantification of protein and DNA).

NuvoGen Research, LLC is a small biotechnology company looking to develop new diagnostic tools for the treatment of cancer.List of Duties and Responsibilities:- Design, perform, and analyze experiments to optimize single cell sequencing.- Experience in quantitative gene expression, cell culture, FACS, and next generation sequencing.- Train and mentor undergraduate students to perform independent sequencing projects.- Lab manager and administrative responsibilities including ordering lab supplies and approving time sheets.

Tucson, Arizona, Us

Doctoral Thesis: Differential Splicing of the Large Sarcomeric Proteins Titin and Nebulin is Developmentally Regulated and is Altered in Genetically Engineered Mice- Strong work ethic which led to authorship on seven publications related to neuromuscular disease.- Presented and communicated research projects at nine national and international research conferences.- Performed histopathological analysis from genetically engineered mouse models in the field of cardiovascular and skeletal muscle disease.- Experience in histology laboratory techniques, immunofluorescence imaging, and protein and mRNA quantification.- Collaborated and performed pre-clinical trial of novel muscle activator (deWinter 2013, J Med Genet.).- Mentored undergraduate students on independent research projects.

Doctor Of Philosophy (Ph.D.), Cell/Cellular And Molecular Biology

Bachelor'S Degree, Triple Major In Chemistry, Biochemistry And Molecular Biophysics, And Molecular And Cellular Biology