SUMMARY

• ISO 9001, 13485, 27001 Lead Auditor, & Identity and Access Management Bioinformatics Project Manager & SCRUM Master - Experienced with holding multiple roles
• Project Managed / SAFe SCRUM Release Train Engineer / Agile Practitioner
• Self-starter with strong communication, presentation, relationship building and strategic planning time management, goals setting and task prioritization abilities o resolve complex issues, improve systems/processes and deliver creative solutions
• Mastery of SCRUM Ceremony's, Agile Process Improvement, Waterfall Project Management, Agile development across the companies multiple organizations
• Collaborates and communicates with the stakeholders and ensure client satisfactionTrain and coach members of project groups to ensure delivery.
• Excellent knowledge of Project Management Processes/ Project Controls Proficient with Project and Portfolio Management Tools. (SharePoint, Visio, Excel, MS Project, Access, PowerPoint, etc.)
• Demonstrated record of successful, complex program execution in fast-paced environment involving cross-functional and/or multi-disciplinary and/or multiple-site technical groups.
• Lead Data Architect / Data Engineer / Data Steward/ DBA
• Designed, built, and measured complex ELT jobs to process disparate data sources for a high integrity & quality data asset
• Delivered automated dashboards, reports and executive level summaries
• Clearly documented processes supporting data transformation, data structures, metadata, dependency and workload management.
• Built and reviewed data pipeline for data ingestion, cleansing, aggregation, and readying data for consumption
• ISMS QMS IT Governance, Compliance & Security Auditor
• Demonstrated superior Knowledge of laws, regulations, policies, and ethics as they relate to medical devices, patient privacy, genomics data, Cybersecurity and privacy.
• Directed data gathering, testing, validation, analysis and modeling.
• Delivered risk assessments aligned with ISO and NIST / FedRAMP, HIPAA and FISMA standards
• Delivered SIG questionnaires based on vendor inherent risk and completed implementation of Vendor Risk Assessment frameworks
• Healthcare, Genomics & Bioinformatics Lead
• Displayed foundational and applied R&D experience utilizing bioinformatics, molecular genetics and cell engineering for phenotype modification.
• Effectively worked in collaboration with the Clinical trial Study Leads to develop the study-related documents, case report form design, study protocols, informed consent documents, study manuals, trial master files, and plans
• Effectively monitored the clinical CRISPr-/TALEN ecosystem and bio-engineering competitive landscape to develop strategic goals for NGS pipeline.

PROFESSIONAL EXPERIENCE

Confidential

Project Manager/SCRUM Master

Responsibilities:

• Matrix managed multiple concurrent projects: confidential Coordinated Bioinformatics Analysis as Project Manager and ISO 13485:2016 Medical Device Assessment as Lead Auditor, Creation of Sharepoint compliance portal
• Modern Industries a DoD Subcontractor. Conducted Audit and Assessment of ISO 9001 and 27001 documentation repository in Sharepoint. Install & configure ISO dashboard w/reports in IBM Openpages -
• Identity and Access ISO 27017 audits against Okta Workforce Identity, Thor, OctetString, Oblix Mulesoft LastPass for Business, BeyondTrust Privileged Remote Access, RSA SecurID Suite, CyberArk, Active Directory, and ADManager Plus, IdM Software, Azure Active Directory Identity Services, Sailpoint, Ping, Phaos, SAP MaXware, SAP HANA Modules: MM, GRC, HR, IdM and Application Interface Framework (AIF) -
• Responsible for implementing Agile framework and experience and accommodating that framework to work for distributed teams -
• Strove to de-escalate contentious situations between teams and align parties on a path to move forward - Hands-on QA role in C#, Angular, React.JS, data modeling and data driven design in MS Azure Cloud Hosted Environment -
• Software Used: Galvanize Rsam dashboard Dell Bhoomi, SAP PI, Basis & Cloud Connector & SAP Cloud Platform Integration, Vertica, Redshift, Hadoop, Spark-Databricks, Kinesis Spark-Streamin, Kafka, Tableau, Spotfire, Qlikview, Cognos, SAP Business Objects, AWS, Azure, Docker and Github, Gitlab, Azure Functions, Cosmos DB, Service Bus, Event Grid, Event Hubs, App Service, Signal R, Azure Service Bus, Subscribe and Publish Architecture, Redis Cache. ETL architecture required to maintain a TSQL, SSIS and ADF ETL data integration solution. Archer, MetricStream, Okta IdAM Forge Rock IdM. BI focused ETL, ODI, Oracle RPD and reporting via OBIEE.

Confidential

SCRUM Master

Responsibilities:

• Advised and informed new company leadership on best practices for data warehouse operation and management acting as data warehouse lifecycle SME -
• Prepared investor briefings and trade pamphlets on Bioscience data integration best practices, leading industry applications and required functions such as master data management, entity resolution, data quality assessment, metadata management and the distinction between logical and physical data models, their audience and use. -
• Applied expert knowledge of normalized and dimensional data modeling practices and implementation techniques. -
• Worked with new owners and investors to Analyze company market, and process data, document current and future state business processes and objectives. -
• Advised and informed new company leadership on best practices for data warehouse operation and management acting as data warehouse lifecycle SME -
• Educated new owners regarding CAR-T Managed Care practices, ICD-10 coding and ISO 13485:2016 FDA 21 CFR Part 820, FDA QSR, European Medical Device Regulation (EU MDR) QMS, In Vitro Diagnostic Medical Device Regulation (IVDR) QMS -
• Educated new owners on use of XP, Agile, Kanban and PMI-Disciplined Agile using SAFe 5.0 adapted to research including SCRUM ceremonies, User Story and Enabler Story definition and use of the JIRA tool and Slack to manage SCRUM research teams - Designed, build, and measure complex ELT jobs to process disparate data sources and form a high integrity, high quality, clean data asset • Clearly documented processes supporting data transformation, data structures, metadata, dependency and workload management.
• Built and reviewed data pipelines for data ingestion, data cleansing, aggregation, and readying data for consumption -
• Entry of corporate compliance information into Stormfront Ventures (new owner's) instances of SAP HANA GRC and IBM OpenPages GRC (install & configure) compliance tools

Confidential

SCRUM Master, Data Engineer

Responsibilities:

• Demonstrated ability to create effective logical and physical data models from complex business data requirements. Able to gather data requirements through analysis of system data, analysis of business processes, and interviews with business subject matter expert -
• Delivered Bioconductor Genomics Pipeline for Personalized Medicine & CRISPr cassette design -
• Delivered coordinated OpenVax pipeline prediction of neo-antigens for Personalized Neo-antigen Vaccines in CAR-T therapy -
• Coordinated Design of CRISPr cassette for Myostatin Enhanced Equestrian Embryo Modification -
• Managed Flow-cytometry gating for phenotypic labelling and high-performance cell sorting -
• Conducted Analysis of large molecular datasets such as raw microarray data, genomic sequence data, and proteomics data for research purposes using Python, R and Geneious 11.4 -
• Implementied reporting dashboards for clients in R, Julia, Informatica, Amazon Kinesis Data Analytics, Azure SSAS & Power BI (via DAX), Looker and Tableau -
• ETL/ELT of Genomic datasets using Matillion, Apache Airflow, Sparc in Scala on Hadoop (AWS), Mulesoft, IBM Infosphere, Informatica ETL for a variety of source data formats such as flat file, XML, and JSON. -
• Integration of genomic database access credentials with client Identity, access and compliance solutions -
• Snowflake Data Lake FDN (Micro-Partition) Meta Data Optimization for DML and Query Pruning,, Snowflake (EP) Expression Property entry, Snowfloake Zero-Copy Clone configuration via Global Services Layer Interface -
• Integration and remote operation of client Shibboleth Consortium, Syncope, Soffid IAM, OpenAM,Salesforce Identity, OpenIG, Midpoint from Evolveum LastPass, Gluu, BeyondTrust Privileged, IdM Software, Azure Active Directory Identity, Soffid, Services, Sailpoint, Ping, Phaos, SAP MaXware & ABAP BRFplus framework rule definition, IdM, GRC, (for FedRamp, & FDA 21 CFR Part 820 ) ERWin data modeling managing multiple data model versions, PL/SQL & Microsoft T-SQL.