Graduated from a 14-week full-stack coding bootcamp to learn how to create dynamic web-based software systems using Java. Attended 800+ hours of development, education, and application.

Coordinated daily Pastry kitchen activities including assigning tasks for 15+ staff, training, inventory management, pastry production, and troubleshooting. Drafted new procedures (with photos) for detailed pastry work to improve the consistency, appearance, and quality of pastries and updated existing documents with best practices.

Seasonal baker at Zingerman's Bakehouse Pastry kitchen. Cookie and other pastry production as well as packaging and cleaning.

Procured, set up, and refurbished lab analytical equipment then organized and set up the analytical lab space using 5S methodology. Supported production of molecule of interest for GMP manufacturing/CMC activities. Analyzed in house samples by a variety of methods to support development work.

**Note: Swift Biosciences is now IDT DNA (Integrated DNA Technologies)**Oversaw daily functioning of all aspects of the ISO 13485-compliant manufacturing of next-generation sequencing (NGS) products and components. Responsible for the production of over 75 products in 10+ product families and for the direct supervision of 4 Manufacturing Specialists as well as Labeling staff. Managed Manufacturing efforts to obtain ISO 13485 certification on the first attempt.• Scheduled production of all kits, components, and custom products to ensure on time product availability• Ensured highest standards of quality in Manufacturing through training, documentation, and continuous improvement• Transformed unregulated Manufacturing staff into a quality-conscious ISO-13485 compliant team• Implemented process improvement initiatives including the implementation of automation, creation of the raw material inspection program and retains/lot ends program, and generation of ISO-compliant batch records• Managed inventory of raw materials, WIP reagents, finished goods, and consumables• Supported and troubleshoot production activities in the lab• Investigated quality and customer complaints related to products• Facilitated design transfer of new products from R&D to the shelf, including creation of Manufacturing procedures and workbooks, purchase of raw materials, creation of BOMs, and coordination of the finished goods layout and kit packaging• Coordinated with Marketing and R&D to understand customer requirements and create unique product solutions• Coordinated Manufacturing activities and staff at two simultaneous locations during Swift's move to Wagner Road• Reviewed and approved manufacturing data and batch records• Generated, reviewed, and approved documents, including standard operating procedures, batch records, material specifications, validation protocols, and reports• Executed change orders, deviations, and CAPAs

Oversaw daily functioning of the manufacturing lab and responsible for all aspects of the manufacturing of reagents and kits. Responsible for the direct supervision of manufacturing laboratory staff. Produced all bulk reagents and components.• Coordinated the production of 122 kits and their components to ensure immediate product availability• Monitored availability, expiration, and minimum quantity of all inventory, including consumables, packaging materials, critical raw materials, stock solutions, and finished goods• Assigned work to 2+ Manufacturing employees to effectively meet deadlines• Implemented tools, methods, and training to optimize Manufacturing processes• Worked closely with Customer Service to meet customer needs, fill unusual orders, and manage inventory shelf life• Collaborated with R&D scientists to transfer, validate, and produce new kits• Interfaced with IT staff to generate new reports and customize the inventory database to facilitate manufacturing planning• Wrote and maintained SOPs, worksheets, and job aids for all manufacturing equipment and processes

Developed and validated Assay, Identity, and Purity HPLC and GC methods and performed QC testing of starting materials, intermediates, and finished API in a GMP environment.• Developed HPLC-UV quantitative methods, limits methods, and qualitative methods for the analysis of small molecules• Drafted validation protocols, executed method validation, and documented results in validation reports• Maintained the Reference Standard system as System Owner• Maintained the Equipment system as Subject Matter Expert• Tested starting materials, synthetic intermediates, and finished API samples under GMP regulations• Qualified reference standards for use in GMP QC testing

Managed and executed all functions of the MNIMBS analytical chemistry lab utilizing UPLC-UV, analytical and semi-prep HPLC, SEC/MALS, and LC-MS/MS platforms to support nanotechnology dendrimer research.• Developed and optimized small molecule and dendrimer UPLC-PDA and UPLC-MS assays for quantitative and qualitative analysis and HPLC semi-prep scale separations for purification• Analyzed samples on all platforms in a timely manner for institute members and collaborators• Managed two undergraduate student employees in the lab• Evaluated and modified laboratory processes to optimize for safety, cost, and time• Participated in cross-functional project teams and meetings

Implemented in-house bioanalytical support for product portfolio and oversaw work with CRO partners for clinical and non-clinical method development, method validation, sample analysis, and reporting.• Evaluated bioanalytical needs and implemented instruments, policies, and equipment• Developed small molecule assays for quantitative analysis of lead compound and second generation compounds as well as biomarker, mechanism of action, and metabolite ID assays• Maintained timely and accurate documentation of lab work in an electronic laboratory notebook, analytical methods, and research reports• Reviewed all methods, protocols, data, and reports from our bioanalytical CRO partners for quality, completeness, and regulatory compliance • Supervised contract bioanalytical staff

Oversaw daily functioning of all aspects of a start-up metabolomics laboratory, including chemical inventory & sample management, chemistry & sample preparation, and LC-MS & GC-MS analytical functions. Responsible for the direct supervision of 4 laboratory staff. • Directed daily laboratory activities and maintained project timelines and schedules• Worked directly with staff on development and troubleshooting of methods and instrumentation• Organized and conducted weekly team meetings• Wrote and maintained protocols and SOPs for all techniques in use• Actively sought out new techniques and technologies to improve upon current methods• Interfaced with IT staff throughout custom LIMS application development process

Developed methods for metabolomics sample preparation, automation, and analysis by Q-TOF LCMS. • Developed custom programs for laboratory robotics to automate complex sample preparation• Developed LC-MS methods for simultaneous detection of many compounds from biological samples• Developed multiplex scheme for library building

Provided on-site customer education, product demonstrations, method development, product troubleshooting, and presentations for a variety of mass spectrometry applications, hardware, and software products.• Conducted basic and expert-level training and troubleshooting in the customer’s laboratory• Performed product demonstrations in the field• Presented technical talks at road shows, symposia, and conferences

Responsible for protein ID and characterization that supported structural biology research and 8 open access mass spectrometers for Discovery Chemistry use.• Analyzed samples for protein ID using various mass spectrometry techniques• Wrote reports and communicated results to customers• Supported 3 open access mass spec labs, including training, maintenance, and 24/7 troubleshooting• Performed daily instrument standardization, maintenance, and troubleshooting

Developed and validated quantitative LC-MS/MS methods and analyzed pre-clinical PK samples to support development projects in an FDA GLP regulated environment.• Developed sample preparation, liquid chromatography, and MS/MS conditions to quantitatively assay samples in a biological matrix• Validated and documented assays and sample analysis results in compliance with GLP regulations• Represented bioanalytical interests on PDM cross-function project teams• Created and maintained relevant SOPs and job aides

Responsible for analyzing protein ID samples to support proteomics and structural biology research using various mass spectrometry techniques.• Performed in-gel digestion and extraction of proteins from 1-D and 2-D gels• Documented analytical procedures• Performed daily instrument standardization, maintenance, and troubleshooting

**Note: MPI Research is now Charles River Laboratories**• Prepared pre-clinical histology samples in a FDA GLP regulated environment• Coordinated daily microtomy work for 4-8 staff to meet schedule• Assisted in Necropsy