Shanyn Carr-Wright Email & Phone Number

Pacheco, California, Usa

Upon joining the team as a Manufacturing Chemist at BioCare, I quickly took on a leadership role within the FISH manufacturing department. I performed all the responsibilities of a manufacturing chemist as well as the following responsibilities:• Weekly planning and delegation of manufacturing responsibilities to the manufacturing team• Inter-departmental communication of manufacturing priorities to QC, QA, Accounting, Procurement and Sales teams to meet customer needs and deadlines• Ownership of department deviations, non-conformance reports, and CAPAs• Lead continuous improvement projects for both FISH and IHC reagent manufacturing departments• Document ownership of all department documents within the QMS system including SOP change records• Write, perform, and report on equipment and process validation protocols• Facilitate the transfer of DNA Extraction process from our Southern California location up to our headquarters in Northern California• Root cause investigation for product non-conformances• Improve and maintain inventory tracking systems to reduce variances and improve accuracy of raw material ordering• Schedule and maintain calibrations and preventative maintenance for all equipment as department equipment owner• Department representative for audits• Member of Emergency Response Team

Hercules, California, United States

As a Quality Control Specialist at Bio-Rad I operated and maintained my own lab for ddPCR products. I also assisted in the operations and maintenance of the main QC lab. As part of these duties, I performed the following tasks to ensure the quality of products before release:• Prepare buffers using raw materials and test functionality before release for production use• Functional testing of Diabetes reagents, kits, and instruments• Functional testing and value assignment of kits and components including plate preparation• Functional testing of HPLC kits and components including sample preparation and extraction• Perform stability studies and write reports regarding kit and component shelf life and lifetime functionality• Ownership, maintenance, and troubleshooting of HPLC systems• Investigate and write reports for Out-of-Specification results• Initiate and investigate Quality Notations• Initiate change requests for continuous document improvement• Report test results in SAP

Hercules, California, United States

As a Purification Chemist at Bio-Rad, I worked with the PCR Production group to create testing kits for various diseases, including Covid. I also assisted the Process Development department in creating a procedure to scale up the production of Covid test kits.• Packed and equilibrated columns• Performed cell lysis, centrifugation, sonication, and microfluidizer• Purified enzymes using DuoFlow columns• Ran and analyzed SDS Page gels• Performed multiple types of protein dialysis, concentration (UFDF), and formulation• Ran PCR tests to confirm proper enzyme modification and check for DNA/RNA contamination• Performed in-process testing (pH, concentration, conductivity, etc.)• Responsible for completing production documentation and maintaining quality records to GDP/GMP standards.• Performed process order transactions in SAP• Assisted 5S team in implementing and maintaining 5S practices

Novato, California, United States

As a Manufacturing Associate at BioMarin, I worked within the downstream purification department. In this department, I performed multiple different purification tasks as well as many other support tasks as needed. • Prepared solutions and buffers for both upstream and downstream manufacturing operations.• Titrated harvested cells to the appropriate pH required for chromatography purification.• Performed three types of column chromatography to purify harvested cells.• Performed final filtration and formulation of chromatography eluates.• Aided in custody transfer of formulated bulk to shipping warehouse.• Reviewed logbooks and batch records to ensure good documentation practices.• Suggested SOP changes and updates to improve manufacturing practices.

Master Of Business Administration - Mba, Business Administration And Management, General

Bachelor'S Degree, Biochemistry And Molecular Biology