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

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.
• 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

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.
• 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.
• 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

• 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