Holli Mayer Email & Phone Number

San Diego, Ca, Us

United States

Leading customer training in US and Canada.Designing and implementing customer training for equipment maintenance and best practicesInstructing customers at their location on how to properly maintain and troubleshoot their equipmentPrimarily focused on downstream large scale purification equipment including single-use and chromatography column technologies

United States

United States

Commissioning and Qualification, Maintenance and limited application support of entire downstream portfolioExtensive experience on AKTA automation, method writing, troubleshooting, scale up, tech transferTrain and mentor field engineers on Bioprocess platform and automationDevelop, revise, and instruct global training material, qualification procedures, maintenance templates, test methodsIn-depth customer training on Bioprocess hardware and application75-100% overnight travel domestic + internationalContent creation for novel training platform for internal & external equipment and applicationAdvise on new facility builds, equipment commissioning and qualification, URS support, deviation escalationRemote troubleshooting and field engineer dispatchCustomer training (content generation and presentation), Virtual Reality Training platform development and implementation, Augmented Reality testing and training development

United States

70 - 100% overnight travel, expense reporting and travel booking with SAP ConcurCoordinate and execute maintenance and service calls with customersOrdering and maintaining inventory for service work using Service Max (Salesforce platform)Proficiency in UNICORN software (v. 5.31 - current), troubleshooting, method writing, installationCustomer support/training on new equipment and softwareValidation/IQOQ of AKTAready, AKTAprocess, AKTA pilot600, AxiChrom, BPG, FINELINE, Chromaflow, MPLC, HPLCDocument revision team (global), tech support team (global), EHS wellness team (US+Canada)

Greater San Diego Area

Field service for BioProcess hardware with a focus on purification systems and columns. PMs, Repairs, and Qualification services. AKTAready, AKTA readyflux, AKTAprocess, BioProcess, UniFlux, AxiChrom, BPG, Chromaflow, Fineline, AKTA pilot600My territory is the Western states including Alaska and Hawaii, though the majority of my customers are in California.

Greater San Diego Area

Supervise the drug substance manufacturing of mammalian and microbial productsUnit Operations: -Chromatography (gradient/step elute, flow-through), Column packing (diameter range 10 cm - 45 cm, flow packing & dynamic axial compression), TFF/UFDF, Viral Filtration, Harvest (250 - 1000 L), product pool titration, depth filtration, sterile filtration, assembly & buffer preparation (up to 1000 L), final bulk formulation & filtration, protein refoldingEquipment (Use & troubleshoot): -Pumps (peristaltic & quattroflow), welders, fusers, sealers, UV Spec, LAF/BSC, TFF skid (manual & automated), VF skid, mixing vessels, load cells, scales & balances (perf. weight checks), pH/cond meters & probes, AKTA systems (Pure, Ready, Explorer, Pilot), columns (Asahi, BPG, Axichrom), autoclaves, WFI, osmometerDocumentation/Writing: -GDP, deviation investigation & author, CAPA, batch record review, batch record design & author (over 40 batch records so far), SOPs (equipment, manufacturing, & quality), protocols & technical reports, technical memos, automation for 2 platforms (UNICORN & CCP), Master Control

Greater San Diego Area

Downstream Purification development group for clinical manufacturing. -Lead team in Process Development, Upstream/Downstream Scale-up Operations, Technical Transfer-UNICORN (AKTAexplorer/AKTAready), DeltaV, CCP (write/execute script)-Solution Preparation, Aseptic Operations, Chromatography, TFF/UFDF, Viral Clearance, Formulation, Column packing SME (flow packing, Dynamic Axial Compression, syringe method/hybrid) Lab scale through Process scale-Microbial and Mammalian Downstream Purification Operations-Equipment/Supply Sourcing and Purchasing. Facility and Process Planning, bringing new facility into GMP compliance.-Support Validation activities, IQ/OQ execution-Document generation: SOPs and Batch Records for process, material and personnel flow, new equipment-Company Video: https://vimeo.com/117639984

Novato

-Large Scale Protein Purification for enzyme replacement therapies-Interact and assist in leading a team in a fast-paced and reactive environment to ensure process continuity & quality-Maintenance of 100+ logbooks within cGMP facility for accuracy of SOP reference and monthly review-Product Changeover-Aseptic Technique-Training technicians in Buffer Preparation, GMP Process Flow, GMP Documentaton & Review-Various Column Chromatography techniques (IEX, HIC and Metal Chelating), Large Scale Formulation/UFDF, Column Packing (axial compression), Viral Inactivation, Depth Filtration-Cross-training in large-scale Media Preparation, Metrology/Calibrations, Plant/Facilities & Maintenance, QA-Technical Support (Deviations/CRs/Trackwise), CMMS, LabWare LIMS/MODA Sampling Software, Oracle (E-Business Suite) Systems for Data Management, and Quickbase/Mirashare programs-Inventory management, support in Cycle Counting and adjustments. -FDA/International Audit Preparation and Interfacing with Materials Suppliers-FDA/International Audit support database, scribe, and coordination.-Standard Work Plan development and testing, 5s Lean Manufacturing, Kaizen initiatives.

Normal Heights, San Diego Ca

-Managed a commercial kitchen and assisted in meeting large orders-Developed SOP’s, HACCP’s, & culinary GMP through research & safety implementation protocols-QA/QC for frozen foods business & optimize conditions to ensure a quality product-Developed assays to determine proper organic food stabilization ratios-Assisted in expansion to a national wholesale level via tech transfer to CMO

Hillcrest, San Diego Ca

-BSL-2 microbiology laboratory maintenance -Bacterial culture, tissue culture (cancer cell lines), & sterile technique-PCR and vector cloning & construction of gene fragment library for mMGST-2-Assay development (Bradford, Vector & RE screening)-Frequent use of array of microbiology laboratory equipment-DNA extraction via Mini-Prep/Gel Clean

Uc San Diego, La Jolla Ca

-General laboratory maintenance (BSL-1)-Gel Electrophoresis (SDS & Native PAGE) -Site-directed mutagenesis of 16s rRNA-Isolation & Purification of ribosomes -Bacterial Cloning & Harvesting-Centrifugation, Sonication, Sucrose Gradients, French Press, UV Spectroscopy, Luciferase Activity assay, HPLC & FPLC-Solution & reagent preparation