Danielle Schamp Email & Phone Number

• Work with Product Management to translate customer needs into actionable product features• Plan and prioritize product development and feature backlog• Develop detailed product feature specifications and ensure they’re clearly understood by engineering teams• Write epics and stories that clearly communicate the engineering requirements to the development team• Align product development resources with product priorities set by product management• Work with other product owners to maintain alignment across all teams• Mitigate roadblocks to achieving sprint/release goals• Lead the product-release plans and set expectations for delivery of new functionalities• Ensure that the final deliverables match the original intent of the product

San Diego, California, United States

• Independently onboard and execute medium or high throughput screening (MTS and HTS) campaigns of compound libraries with beginning-to-end oversight, from screening to confirmatory dose response assessment of screen hits.• Develop and validate a variety of assay types, including but not limited to TR-FRET, AlphaLISA, and cell-based assays. Miniaturize and optimize for automation workflows.• Operate Strateos proprietary “smart” laboratory console to automate production, including but not limited to high throughput screening of compound libraries. Provide feedback to software engineers for bi-weekly deployments.• Build and track bioassay metrics to guarantee high quality data integrity. Identify, troubleshoot, and resolve issues as they arise alongside of production while mitigating potential timeline delays.• Set up new tissue culture laboratory; passage and bank new cell lines for assay-ready use, implement new documentation systems, purchase and organize new benchware equipment, build biohazard safety measures.• Draft and finalize SOPs for equipment and for individual bioassays. Design, implement, and improve documentation practices to capture activities external to the automation records.• Maintain and optimize top-of-the-line equipment across the laboratory, particularly liquid handlers (e.g. GNFWDII, Formulatrix Tempest, Labcyte Echo).• Proficiency in Prism, Green Button Go (GBG, by Biosero), NiceLABs (by EQUIcon), and Tempo (by Beckman/Labcyte).• Manage day-to-day laboratory operations, from inventory upkeep to scheduling

San Diego, California, United States

In addition to Associate Principal Investigator I (below):• Ensure the creation of projects, study files, and setup of the LIMS.• Communicate new projects/protocols and any updates to the Master Schedule to applicable Intertek personnel.• Ensure the protocol and amendments are provided to all personnel involved in the study in a timely manner.• Coordinate sample receipt, tracking, and storage, and ensure any necessary communications to the site or client. Assure that discrepancies are accurately reconciled and documented.• Create prep batches/run lists, worksheets, and/or plate setups in LIMS.• Ensure accurate record keeping with regards to Sponsor’s samples, data, and reports. Ensure that analysis is performed according to the protocol and the Sample Analysis Plan.• Train new Associate Principal Investigators• Compose, revise and review SOPs.• Responsible for general lab safety with regard to employees and clients.

San Diego, California

•Validate and troubleshoot bioanalytical methods for the purpose of sample analysis to be compliant with 2016 FDA Guidance, GLP, and Intertek SOPs.•Spearhead working groups to put business and scientific initiatives into practice, including but not limited to implementing Watson LIMS and SoftMax Pro into the validation team, creating template tables for the validation team, and re-organizing the company server file organization and naming convention. •Ensure that Analysts are qualified on applicable bioanalytical methods prior to performing assigned tasks.•Collaborate with client services and Principal Investigator to monitor the status of each assigned project and communicate with the Study Director and/or Sponsor contact with regards to the progress.•Ensure accurate inventory of supplies for laboratory operations is maintained to execute assay schedule.•Initiate, prepare, and finalize SOP, protocol, bioanalytical procedure, and any deviations. Notify the Study Director and/or Sponsor as applicable.•Communicate revenue status for forecasting and monthly revenue projections.•Create prep batches/run lists, worksheets, and/or plate setups in LIMS.•Review analytical runs according to Intertek SOPs and current regulatory guidelines.•Ensure accurate record keeping with regards to Sponsor's samples, data, and reports. Ensure that analysis is performed according to the protocol and the Sample Analysis Plan (SAP), if applicable.•Ensure that data table generation, data review, and bioanalytical report creation is performed according to Intertek SOPs, and all are acceptable for QCC or QAU review.•Respond to the QCC and QAU inspections and audit reports promptly, indicating the corrective actions.•Coordinate the finalization of bioanalytical reports.•Responsible for the timely transfer of data, reports and other records to the Sponsor.•Follow GLP guidelines and Intertek SOPs, and maintain a safe working environment.

San Diego, California, United States

• Worked onsite in the Intertek Pharmaceutical Services Immunochemistry laboratory as a contracted worker by Aerotek Staffing Agency until converted to a direct employee in May 2016.• Readily complied with all FDA GLP guidelines and company SOPs in laboratory safety, technique, and documentation• Analyzed serum and plasma samples from humans, cynomolgous monkeys, dogs, rats, and other test subjects using a variety of analytical ELISA-based platforms • Worked within a small team to develop and validate assays for a host of clients in the pharmaceutical industry• Organized documentation for samples, raw data, reagents, and reports for numerous projects

San Diego, California

• Constructed lesson plans for large and small-group settings• Co-created and managed a website, particularly the calendar event content and program descriptions• Communicated with parents of youth for safety, lesson material, and event purposes• Created and distributed advertisements for various youth programs• Responsible for twenty or more children between the ages of eleven to seventeen• Hosted meetings to ¬¬orchestrate lessons and events and recorded meeting minutes and distributed to team afterwards• Lead a team of 13 high school students and adults to execute plans while maintaining flexibility for inevitable adjustments

La Jolla, California

• Examined nano-sized microvesicles (exosomes) excreted by peri-islet mesenchymal stem cells as a candidate antigen for type 1 diabetes• First-hand experience working in the laboratory in scientific research• Trained to use and operated state-of-the art technology• Work in a diverse multi-cultural team-based environment• Conducted various complex experiments, analyzed data collected, and presented data in meetings. Proficient in various experimental protocols, including mouse dissection, pancreatic islet isolation, splenocyte isolation, western blot, FACS acquisition and analysis, ELISA, cell culturing, PCR, vertical and horizontal gel electrophoresis, DNA primer design, and bacterial plasmid cloning• Handled administrative needs of the laboratory, including scheduling meetings, inventorying, ordering, and stocking laboratory equipment, cataloguing past experiments and their data, coordinating with external labs and companies, and handling shipping of samples• Coauthored publications and posters, which were presented in multiple scientific conventions

Greater San Diego Area

• Tutor high school students to do well on the SAT and ACT tests• Teach in a number of environments, including one-on-one and classroom settings• Communicate with students’ parents on strengths, weaknesses, and progress of the students as lessons continue• Schedule and organize lessons, homework, diagnostic grades, and notes on progress of individual students

La Jolla, California

• Examined nano-sized microvesicles (exosomes) excreted by peri-islet mesenchymal stem cells as a candidate antigen for type 1 diabetes• First-hand experience working in the laboratory in scientific research• Trained to use and operated state-of-the art technology• Work in a diverse multi-cultural team-based environment• Conducted various complex experiments, analyzed data collected, and presented data in meetings. Proficient in various experimental protocols, including mouse dissection, pancreatic islet isolation, splenocyte isolation, western blot, FACS acquisition and analysis, ELISA, cell culturing, PCR, vertical and horizontal gel electrophoresis, DNA primer design, and bacterial plasmid cloning• Handled administrative needs of the laboratory, including scheduling meetings, inventorying, ordering, and stocking laboratory equipment, cataloguing past experiments and their data, coordinating with external labs and companies, and handling shipping of samples• Coauthored publications and posters, which were presented in multiple scientific conventions

Bachelor Of Science (B.S.), Microbiology, General, 3.129

Minor in Literature/Writing

High School Diploma, 4.2

Activities and Societies: Drum Major, 1st Chair Flautist, and Field Assistant in Marching Band (Serra High School Golden Regiment).