Natalie Astraea - VP Operations,

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Work Background

Huntington Medical Research InstitutesDirector of Operations & EHS

Jan. 2023Los Angeles, CAAdvanced leadership position overseeing the Core Resource Program, research infrastructure. Responsible for performance of research operations, consolidating systems across labs and departments to support global operations, deliverables, data management, asset management, financial management, research study execution. ▪ Implementation of organization-wide management systems and workflows to support seamless procedures for inventory, purchasing, receiving, data management, safety, lab trainings and biobank management. ▪ Complete oversight of compliance and EHS programs. Identifies hazards, evaluates loss potential and designs and implements loss control programs. Monitors adherence with chemical safety, biosafety, and environmental safety procedures. ▪ Ensures compliance with regulations issued by OSHA, Cal/OSHA, EPA and other government agencies. Oversees compliance calendar to adhere to Federal and State guidelines.

Huntington Medical Research InstitutesSenior Director of Operations; Head of Clinical Research

Jan. 2022Los Angeles, CAAdvanced-to-executive leadership position, capitalizing on operational achievement and industry knowledge to define methods that enhance all systems at HMRI. Oversight of Clinical and Pre-Clinical Research programs, the Core Resource Program including Analytical Biochemistry Core, Research Services Core, Imaging Core, Central Biorepositories (Biobank and Brainbank), and Research Facilities. Maximize resources of multiple labs and cross-functional departments. Focus on biomarker detection methods including quantification of compounds and interactions within biological and synthetic matrices to accurately measure disease status and risk, and facilitate treatment research. Provide leadership to personnel, providing effective training and mentorship. ▪ Implement optimized workflows and systems for asset management, inventory, acquisition, maintenance schedules, data management, compliance, trainings, and operational platforms (ERP, LIMS, QMS, and Netsuite). ▪ Guarantee regulatory compliance with OSHA Cal/OSHA, EPA, FDA, NIH, AAALAC, and all required agencies. ▪ Serve as the Institution’s Chemical Hygiene Officer, leading the Safety Committee and acting as the technical SME for the IBC while engaging in drafting and review of protocols surrounding biological agents and hazardous chemicals. ▪ Champion safety, health, and environmental initiatives to elevate compliance and capture efficiency gains. Align training efforts with federal/state safety guidelines, providing education to internal teams on current industry processes. Implement strategies to ensure adherence to chemical safety, biosafety, and environmental safety standards. ▪ Facilitate development, implementation, and validation of complex methodologies and infrastructure. ▪ Responsible for global operations including Laboratories, Vivarium, Facilities, Clinic, Biostatistics, IT, and business development. ▪ Negotiate, prepare and execute master service agreements, including oversight of research programs. Provide leadership for dynamic collaborations in disease detection and onset prediction. Complete oversight of Shared Resources for internal and external partners.

Huntington Medical Research InstitutesLab Manager, Analytical Biochemistry Core & Neurosciences

Jan. 2022 - Jan. 2023Los Angeles, CAOversight of Analytical Biochemistry Core and Neuroscience Labs, leading implementation of Quality Assurance and LIMS platforms. Maintained accountability for lab instruments and equipment including ion chromatography, gas chromatography, liquid chromatography, thin layer chromatography and mass-spectrometry tools. ▪ Developed, optimized, validated and ran high complexity analytical assays to support institutional and external research aims. ▪ Streamlined asset management; consolidated service contracts and maintenance schedules. ▪ Co-authorship of publications and presentations, representing organization at seminars and key meetings. ▪ Supervised technicians, post-docs and research associates to facilitate the programs of the Biomarkers and Neuro-disease Mechanisms Lab and Cognition and Brain Integration Lab. ▪ Fostered a collaborative environment amongst researchers, steering projects while adhering to safety protocols. ▪ Trained and developed lab personnel on assays and precise equipment usage, assigning and allocating assignments to Analysts, Research Associates and Technicians.

Consumer Safety Analytics LaboratoriesOperations and Quality Manager

Jan. 2021 - Jan. 2022Led monitoring and data reporting of lab operations, reporting key results and insights to the President and Chief Scientific Officer. Kept up to date of internal/external procedures specializing in ISO/IEC 17025, CDPH and FDA standards. Engage in clear communications with lab staff to ensure alignment with quality standards and compliance standards. Managed top-performing Quality and Operations Specialists. ▪ Oversight of all aspects of quality, lab, and intake operations. Functioned as subject matter expert for Quality, Safety, and Operations teams, directing interdepartmental meetings with senior lab and executive personnel. Offered thought leadership into troubleshooting compliance issues impacting the full range of laboratory functions. ▪ Served as the primary resource for external audits, collecting required documentation for submission and reporting supplemental data necessary during audit periods. Achieved and maintained A2LA ISO and other certifications. Facilitated successful local, multi-state, and federal regulatory audits while adhering to compliance calendar. ▪ Established processes across multiple departments, designing operational processes to fulfill client expectations. ▪ Led efforts for LIMS configuration, optimization, training, implementation, and management. ▪ Maintained instruments, developed and implemented test methods, trained lab teams, and defined quality controls resulting in standardized assays for biological and synthetic matrices. ▪ Communicated applicable federal and state regulations to internal and external partners, guiding individuals on best practices and resolving client-centric compliance concerns.

Lazarus NaturalsResearch & Development Scientist

Jan. 2018 - Jan. 2021Established Quality, Production, Operations, Stability, and R&D Labs, scaling operations through design of systems, methodologies, product development and validations. Performed extensive environmental, chemical, and physical analyses. Oversaw multisite lab and manufacturing facilities buildout to support commercialization of novel products. Supervised teams within the R&D, QC, and Production departments. ▪ Participated in new product innovation through bench level experiments, materials production and sourcing, manufacturing systems optimization, and commercialization. ▪ Led formulation development, testing, and validation for cosmetics, supplements, ingestible, and novel nutraceuticals. ▪ Recruited, hired, and trained qualified lab personnel to surpass performance expectations. ▪ Applied expert technical writing skills to generate SOPs and best practices for all lab functions, additionally designing management roadmaps and training documentation. ▪ Produced commercial scale multi-crop cultivation systems from the ground up. Built out and optimized sustainable building materials including bio-composites. Introduced waste mitigation, sustainability, and renewable resource integration processes. ▪ Effectively managed external contracts to ensure compliance including government agencies, contractors, and suppliers. ▪ Oversight of all aspects of R&D, Quality and Production lab operations.