Daniela Silva Email & Phone Number

Carlsbad, California, United States

• Generate documentation (item specifications, batch records, SOPs, bills of material, production summaries, etc.) based on inputs from the development team and requirements/constraints provided by the manufacturing.
• Support the execution of engineering/pilot runs for viral production and purification processes and train manufacturing staff independently on transferred processes as needed
• Proactively identify process gaps and/or inefficiencies, perform root cause analysis, and propose solutions
• Source materials internally/externally for the completion of full-scale pilot runs and define final material andlabor requirements for Manufacturing
• May lead projects in transferring processes from development to manufacturing by collaborating cross functionally with both internal and external stakeholders and participating in project readiness reviews
• Provide additional support and cross-train as business needs arise

San Diego, California, United States

• Serve as the lab operations representative and SME on product development teams: driving strategic LabOps planning, process improvement activities, as well as managing execution of project deliverables and product.
• Core Team project member working cross functionally with project management, development teams, lab operations and supply chain to coordinate analytical Validations, process validations, and scientific experiments.
• Author of process validations and validation reports, responsible for writing test steps and ensuring end-to-end workflows are captured during validation testing.
• Monitor and coordinate validation testing and conduct training activities for validations, as well as monitoring the execution of all validation modules. Ensuring that all necessary individuals have access to.
• Responsible for creating material estimates for development and validation activities, as well as ordering materials through internal and external vendors.
• Create and finalize Bill of Materials based based on input from the development team, ensuring that all inventory needed for each project is obtained.

San Diego, California, United States

• Assist with new product launches by transferring expertise from development teams to CLIA lab.
• Assist with creating and maintaining capacity models for existing laboratory workflows
• Assist with acquisition of Equipment and Capital Expenditures.
• Work with multidisciplinary teams to drive project completion.
• Edit and author technical documentation in conjunction with Development, CLIA Laboratory, Supply Chain Management, and Quality Groups.
• Implement improvements key company processes that support our mission of building a world- class clinical laboratory.

San Diego, California, United States

• Liaison between management and the lab
• Ensure production personnel are operating in their designated areas
• Communicate any scheduling gaps with shift supervisor and assist supervisor with scheduling
• Ensure all needed materials are in place and available for production personnel at the start and during the shift
• Assist production personnel in resolving job related problems
• Address process issues before they escalate to significant process interruptions as much as possible

San Diego, California, United States

• Assist CLS with automated steps in the analytic testing phase for patient diagnostic testing under direct and constant supervision of licensed CLS.
• Track and report all lab incidents.
• Serve as a point person for general troubleshooting issues in the pre-analytical processes in the absence of the supervisor.
• Actively share information to supervisor, to the team, and cross functional teams as needed.
• Assist and provide feedback for on-site interviews for both CLS and CLT potential new hires.
• Help maintain an organized and safe work environment by ensuring work areas adhered to 6S standards.

San Diego, California, United States

• Extract DNA from saliva samples in a BSL2 Laboratory.
• Daily operation of liquid-handling robots and array scanners to meet daily and weekly production goals.
• Adhere to SOPs for all processes of the lab including but not limited to processing DNA samples through the Goldengate and Infinium assays.
• Carry out daily/weekly/monthly maintenance schedules to ensure that the laboratory equipment is operating properly.
• Maintain lab supplies and consumables.

University Of San Diego

In my research I use frustrational analysis to guide mutational studies of NHE1, CHP1 and CHP2 to determine the amino acid residues that participate in the binding and regulation.

University Of San Diego

I mentor and tutor middle school children at Montgomery Middle school. As well as create work schedules and maintain communication between Montgomery middle school and the University of San Diego.

Prepare solutions and bins of materials AP Chemistry & Biology labs request, before the session.Help out the teachers during the session, as well as help clean up after the session, wipe bench tops, wash glassware, and put chemicals and equipment away.

University Of San Diego

I mentored incoming freshmen who were joining the Student Support Services (SSS) program which is jointly funded by the U.S. Department of Education and the University of San Diego to serve eligible undergraduates at USD. The program provides opportunities for academic development, assists students with college requirements, and serves to retain and.

Bachelor’S Degree, Biochemistry

Activities and Societies: Movimiento Estudiantil Chicano de Aztlán (M.E.Ch.A), Students For Life, Chem Club, Student Support Services, USD.

High School