Osha-10, Hazwoper-40, NIOSH 582, MA/ME licensed air monitor

Biocytogen is a CDMO specializing in humanized mice. They had recently moved into new space in Waltham and my responsibilities were divided in three areas: exiting the previous facility, stabilizing the vivarium operations, and enhancing the main lab functions. Following three months of marked and remarkable accomplishments, there was a downsizing event and my position was terminated. A brief summary of my accomplishments there include:• Took full ownership of the process exiting the previous facility lease on a short timeline.• Exit activities included identifying vendors and obtaining quotes for office furniture removal, chip tank, generator, and HVAC reports and servicing, equipment relocation, plumbing repair, room cleaning, lab decontamination, and other general restorative activities to the interior and exterior of the space.• Installed and monitored Innovive mouse cage racks; reviewed and improved protocols for handling and sterilization of animal food and bedding; initiated cage material recycling program.• Created protocols to AVMA guidelines regarding euthanasia.• Authored the OLAW assurance letter and championed NIH submission for work with grant-subsidized clients.• Authored numerous operational protocols in order to initiate a GxP environment including the calibration of balances and digital calipers as well as chemical waste disposal.• Augmented the cold storage temperature monitoring footprint and authored documents defining the operating parameters and alarm response ownership. • Acted as EHS and Biosafety committee chairs, which included creating lab inspection templates and processes for vetting potential new hazardous research materials. Key Skills/Techniques/Instruments: Vivarium, Innovive racks, Elemental Machines, QMS, Netsuite, Lease termination, BSL2

First on-site employee at remotely founded startup responsible for building an research lab from the ground up. • Budget forecasting for equipment purchasing, facilities maintenance, and safety activities• Chemical and BL2 biological waste management and disposal• Lab and office space planning, utilization, expansion and beautification• Safety document development (chemical hygiene, emergency action, biosafety manuals)• Internal expansion and facility adjustments (HVAC / plumbing/ electrical fitting)• Equipment alarm monitoring for cold storage and incubators• Establishing an IT infrastructure, from vendor relationship to hardware integration• Identifying and implementing purchasing and LIMS systems for compound registration• Attending to all additional on-site administrative services (lab coats/dry ice/gas delivery/drinking water)Key Skills/Techniques/Instruments: BL2 Startup initiation, Lab expansion, Real estate evaluation, Equipment purchasing, International logistics (China)

Formerly known as Torque Therapeutics and Cogen Immune Medicines.Duties include harmonizing equipment and facility maintenance across two sites as well as safety, ordering supplies and developing vendor relationships, and improving organization and efficiency in lab processes, shipping, receiving, and safety permitting activities, and coordinating chemical and biohazardous waste disposal. • Act as flow core manager for daily maintenance and troublehooting.• Operate and perform preventive maintenance on systems such as cryogenic storage units and other cold storage, biosafety cabinets, and incubators. • Organize and initiate processes to improve HVAC and electrical systems.• Responsible for hazardous materials and recombinant DNA permitting.• Act as emergency coordinator and on call 24/7 for lab-related issues.Key Skills/Techniques/Instruments: BD FACS Celesta Flow Cytometer, Nexcelom K2 and MX Cellometer, Cryogenic Storage, Steris Autoclave, Lancer Dishwasher, Safety and Compliance Audits, Hazardous Waste Disposal

Relocated to Houston, TX.First full-time employee at startup charged with establishing all laboratory and manufacturing capacities for novel PCR technology.• Established vendor contracts and relationships to procure crucial materials in a timely manner, ordered lab supplies and specified capital equipment• Exhibited proficiency in key manufacturing techniques such as microarray printing, laser cutting, and silane chemistry with minimal training and oversight• Established chemical waste inventory and disposal systems, and maintained the laboratory through cleaning and facilities managementKey Skills/Techniques/Instruments: Microarray Printer, Laser Engraver, Materials Procurement, Vendor Relationships, Safety Administration

QC/QA chemist in group that manufactures multi-curie quantities of reactor-born radionuclides, including Yttrium-90 as an Active Pharmaceutical Ingredient in a GMP setting as well as numerous additional GLP isotope products. • Perform chemical assays to support Yttrium-90 production for use as an Active Pharmaceutical Ingredient (API) in chemotherapeutic applications, including Thin Layer Chromatography (TLC), Inductively Coupled Plasma (ICP-OES) emission spectroscopy for the detection of trace metal impurities and Gas Flow Proportional Counting for determination of radionuclidic ratios• Complete process and equipment qualifications and validations to support ongoing manufacturing processes• Conduct internal audits and effectiveness checks across multiple departments and sites to support ISO9001:2015 standards• Act as group document coordinator of a GMP product line to maintain compliance with quality and radiation safety guidelines, including ICH-Q7 and 21CFRKey Skills/Techniques/Instruments: Thin Layer Chromatography, Ion Exchange Chromatography, Induction Coupled Plasma Atomic Spectroscopy (ICP-OES), LAL Endotoxin Testing, GMP Document Coordinator, Certified ISO9001:2015 Internal Auditor

Technology transfer lead for two chip-based microfluidic products used in the analysis of DNA/RNA/Protein samples, coordinated reagent manufacturing and testing as well as numerous cross-functional projects including establishing a class 10k clean room environment for the formulation and dispensing of FDA regulated products.• Lead associate technicians in the production and testing of the RNA/DNA analytical microfluidic electrophoresis products using an automated dispensing system in a clean room setting• Responsible for coordinating the industrial scale dispensing and packaging of bulk reagents for the creation of 10,000 kits annually in accordance with Lean manufacturing principles• Act as certified ISO9001:2008 internal auditor as well as group document coordinator responsible for group quality assurance• Assist with CAPA/FMEA process to assess risk and handle customer complaints• Coordinate special projects with Quality and EHS personnel to generate material safety data sheets in compliance with international trade regulations• Initiate cost savings and workflow improvements to reduce labor and scrap as well as enhance automation within the process• Responsible for procuring non-inventory and Kanban consumables as well as sourcing materials and qualifying vendors Key Skills/Techniques/Instruments: Caliper LabChip XT, Caliper LabChip GX, Agilent 2100 Bioanalyzer, Codesoft (SQL) Administrator, SAP

Technology pivot away from lithium batteries resulted in merger to form SC Therapeutics, Inc.Laboratory lead in the development and manufacturing of an early-stage startup making a Li/Al battery to use as an actuator in a patch-pump medical device. Designed experiments to optimize materials and conducted partnering activities with pharmaceutical suppliers and prototype studies in animal models. • Developed electro-mechanical assembly and materials processing techniques from experimental phase to FDA-regulated processes, including clean room policies to meet ISO13485 and CFR820 standards, compliance training, and manufacturing protocols and batch records • Provided support for the development and implementation of validation procedures (IQ/OQ/PQ) to gain CE Mark certification and reach quality milestones• Manufactured components of a proprietary electrochemical cell for use as an actuator in a patch-pump device in a clean room setting, including soldering and computer-aided testing with Maccor and VMP3 instruments, discharge circuits, Keyence sensors and flow-cell spectroscopy• Scaled-up manufacturing process from research phase experiments into commercial level production line capable of producing 30k units annually• Performed the role of group leader to assist in the hiring and training of technicians and to oversee their work with regard to standards of quality and documentationKey Skills/Techniques/Instruments: Bradford Coomassie Total Protein Assay, Flow Cell Spectroscopy, Electrochemical Evaluation involving VMP3/Maccor Potentiostat, Instron Texture Analyzer, Operational Process Validation and Documentation (IQ/OQ/PQ)

Technology transferred to West Coast into the Protein Simple, Inc. catalog.Vital lab role at a startup making an acrylamide platform which fractionated protein samples by isoelectric point. Manufactured existing protein platforms and helped develop additional peptide and analytical applications as well as coordinating reagent formulations and packaging.• Maintained inventory and distribution of reagent consumables by manufacturing buffers, stains, and detergents and chips• Developed more efficient production methods through experimentation with a variety of polymerization initiators and conditions, including surface coatings and plasma treatments• Coordinated with marketing and sales personnel to create new product lines of Western Blot consumables• Worked closely with engineers to develop more effective methods and processes for Lean manufacturing and product development• Authored protocols for work in a GMP-compliant Class 10k clean room to produce reagent consumables for a commercial product lineKey Skills/Techniques/Instruments: Digital Proteome Chip, Acrylamide Polymerization, Western Blots, Plasma Treatment, Surface Adhesion Chemistry

Chemist in charge of the synthesis, purification, and analysis of custom RNA/DNA oligomers and nucleosides. • Performed complete production of custom RNA/DNA oligomers for commercial sale, from customer order through shipping• Purified RNA/DNA products as well as phosphoramidites by column chromatography using Sephadex, silica and resin columns and cartridges• Designed purification techniques and authored technical data sheets for specially modified oligomersKey Skills/Techniques/Instruments: Solid Phase Synthesis, Size Exclusion Column Chromatography, UV/VIS Spectrophotometry, Capillary Electrophoresis, Certificate of Analysis