Maryel Gonzalez

About Maryel Gonzalez

Extensive professional experience in Quality Control, Research and Development and Project Management with strong technical background with excellent communication and interpersonal skills Demonstrated history of working in the pharmaceutical and biotechnology industry; Excels in development and continuous improvement of laboratory procedures, ensuring compliance with relevant regulatory agencies with experience in GLP and GMP environment. Strong operations professional, graduated from Higher Institute of Nuclear Science and Technology in Radiochemistry.

Experience

1. Manager of Qc and Assay Development Groups

   GBI Bio

   Jul 2010 — Present · Plantation, FL, US

   Responsible for the functioning and planning of the daily laboratory operations and overall performance of the QC and Assay Development groups in co-ordination with project management and clients- Design and supervise the development, qualification, validation and method transfer of bioanalytical methods based in ICH guidelines and FDA regulations- Design and supervise the development of new bioanalytical methods to evaluate the different quality attributes of the products- Review and approval of the departmental SOP’s and develop quality system to ensure compliance to regulatory requirement and applicable principles of GLP and GMP- Oversee the quality of the documentation, data generated, summaries and reports in compliance with GMP and GLP standards- Prepare and plan the training of the analyst and technical personnel to Assay Development and Quality Control and provide technical support to other department when needed such us upstream and downstream development and manufacturing- Design and supervise the execution of buffer formulation stabilities studies of mAb in solution- Indentify resources required for the smooth functioning of the department including equipment and personnel. Contact the outside vendors to present seminars and conduct training to keep abreast with new technologies and products- Write protocols and supervise the execution of accelerated and real-time stability studies for the Drug Substance (FBP) and Drug Product (FVP) manufactured including Force degradation studies and stability of the product’s intermediates- Interact with the Business development and project management groups for pricing and feasibility of new proposal for potential clients. Assist in interacting with clients and making recommendations and resolutions for new projects that involve assays to be developed- Participate in Quality Audits whenever required.

Education

• Higher Institute of Nuclear Science and Technology

  Radiochemistry

  1990 — 1995

Skills

• Vaccines
• Biochemistry
• Enzyme Assays
• Microsoft Excel
• Capa
• Bca Protein Assay
• Tlc
• Quality System
• Cell Culture
• Validation
• Isoelectric Focusing
• Monoclonal Antibodies
• Uv/Vis
• Assay Development
• Microsoft Office
• Analytical Chemistry
• Quality Assurance
• Chromatography
• Cell Biology
• Pharmaceutical Industry
• Sop
• Fda
• Bradford Assay
• Quality Control
• Gmp
• Analytical Method Validation
• Biotechnology
• Protein Purification
• Biopharmaceuticals
• Elisa
• Radiochemistry
• Uv
• Sds-Page
• Radiation Safety
• Binding Assays
• Stability Studies
• Regulatory Affairs
• Lifesciences
• Purification
• Fda Gmp