Ciera Dolechek Email & Phone Number

Denver, Co, Us

Durham, North Carolina, Us

• Authored, revised, and reviewed production records, technical documents, batch tickets, and sample plans for NPI/PRI campaigns• Built and updated multi-level campaign bill of materials (BOMs) for NPI/PRI’s• Executed equipment changeovers for campaign introductions, ensuring compliance with requirements• Redesigned a paper-based equipment changeover process and built an electronic universal work plan template to reduce labor hours by 90% (1,710 hour time savings).• Provided on call technical downstream biopharmaceutical processing support of commercial and clinical cGMP runs in addition to process monitoring through Unicorn and Pi Vision/Historian• Performed chromatography review to ensure method execution, elution profiles, and process parameters were consistent• Supported deviation and CAPA investigations and collaborated as a subject matter expert to provide troubleshooting, root cause analysis, process impact assessments, and corrective action • Accompanied clients on the floor for unit operations and conducted client-facing troubleshooting for unit operations • Managed multiple skids as system owner, performed periodic validation reviews, executed data analysis to optimize performance, and scheduled maintenance. • Investigated alarms on equipment and organized immediate paths forward• Executed process improvements by correcting master document errors • Authored PPQ protocols and summary reports• Implemented technical transfer of NPI/PRI’s into manufacturing and collaborated cross-functionally to ensure process change compliance• Analyzed and compiled process data, communicated and presented updates to client• Performed data entry and verification of IPC's and CPP's• Assumed the role of site representative for material harmonization for SAP• Initiated temporary and permanent change controls • Provided training to onboard employees to MS&T, mentored P-Tech high school students, and served as a liaison for a CU Boulder Senior Design Project

Lakewood, Colorado, Us

• On a global scale, provided day to day sustaining engineering support on an apheresis medical device platform• Investigated root cause and authored over 600 formal complaint write ups with system level performance recommendations • Organized and aligned several engineering teams globally in investigating top quality issues by initiating project planning, designing experiments, training associates on process, performing testing, facilitating meetings, and offering extensive technical expertise • Performed in depth data analysis and prepared productivity results for paper abstracts and global presentations• Provided real time support to the manufacturing floor when issues arose during device check out procedures• Supported release of new software and new electronic box at routine use trial sites through reliability analysis • Provided week long training to internal associates on function and system knowledge of medical device • Organized cross functional team meetings with disposable, equipment, and software engineers on a bi-weekly basis to review significant emerging issues that entailed technical input, presentation of results, and severity determination • Executed queries to examine platform productivity and trending issues in both a proactive and reactive approach of problem solving• Assisted in the determination of reportability decisions for regulatory reports such as medical device records

Lakewood, Colorado, Us

• Identified root causes for unexpected system results and provided feedback to the customer and technical specialists across North America• Used internal tools to predict and optimize customer processes• Designed an interactive tool from start to finish for internal associates and customers in the field to use• Acquired and analyzed data through queries• Aided in the development of internal software tools including the verification and validation of the end product• Traveled to customers sites to perform process optimization reports

Lakewood, Colorado, Us

• Authored a 160 page system verification report on a medical device platform, lead the design controls baselining efforts through product requirement documents and lower level requirement authentication and tracing, and held several multiple disciplinary design reviews• Submitted regulatory document for equipment useful life that involved extensive retrospective analysis and was later audited by regulatory agencies• Performed remediation of risk analysis• Performed system level and software level verification tests in internal labs• Provided onsite clinical trial support for a new software release• Executed clinical data source verification

Lakewood, Colorado, Us

Project Planning and Management• Researched, planned, and executed a comparative study measuring the survival of multipotent MSCs encapsulated in natural and synthetic three-dimensional scaffolds after undergoing expansion on the Quantum cell expansion system versus flask-based expansion• Determined the appropriate procedure and composition for a collagen based and a poly(ethylene glycol) diacrylate based hydrogelCell Culture Experience • Prepared and changed media and reagents in automated and flask-based environments • Utilized cryopreservation and calculated seeding densities • Measured cell viability using Vi-Cell and assessed glucose and lactate levels using an i-Stat device to determine the optimal time to harvest cells through trypsinization • Stained and performed live/dead assays for imaging • Practiced aseptic techniques and autoclaved suppliesPatent • Designed a functionally closed platform to encapsulate mesenchymal stem cells into a photo-initiated hydrogel. Docket Number PG0332-IDLeadership• Mentored a high school teacher participating in Research Experience for Teachers program (RET) through the Bioscience Institute for several weeks

Publication• Acknowledged in the paper published by BioRxiv titled, “Cardiac myocytes respond differentially and synergistically to matrix stiffness and topography”Programming• Developed an object detecting Matlab program to calculate the fractional shortening, area, beating frequency, and aspect ratio of neonatal rat ventricular myocytes throughout the cardiac cycleHydrogel Overview• Produced, characterized, and analyzed cardiac cells cultured on hydrogels that mimicked both healthy and diseased cardiac tissue• Measured the Young’s modulus of different cross-linked and patterned hydrogels using a rheometer