SUMMARY:

• Helping clients define an IT Strategy & a DevSecOps Maturity Model, Capability Map, Ownership and Resourcing - strategy; DevOps PaaS & a collaborative culture between App, Platform, Security & Infrastructure
• Stood up multiple Cloud-native DevSecOps platforms and services, instilled best-practices, cloud-native Ops-Automation + Ops-Compliance towards consistently achieving cost-efficiency, while ensuring security best practices across multi-cloud solutions (AWS + Azure-DevOps).
• 18 years of experience with LifeSciences/Pharma, GxP Regulatory compliance, Software Validation SDLC Processes and CFR-Part11.
• Technology-strategy, Portfolio-planning & hands-on delivery for 10+ yrs for global organizations (NA, EU, APAC and LATAM), serving worldwide Clinical clients, utilizing dozens of vendors & their hosted-solutions
• Responsible for Information-Security Gap/ Compliance Assessments and Remediation/Risk-compensation plans. Consistently maintained a company-wide reputation for solutions with low security risk profile.
• Authored Security Best-Practice patterns with code-samples and implementation guidelines
• Led technology due-diligence and pre-integration planning for a Joint-Venture (Q2 Solns), Led post-acquisition Integration-assessment Confidential .com. Defined integration & security investment-plans. Led initiatives involving market-research & due-diligence of other acquisition-candidates.
• Technology Lead for all due-diligence activities related to product or vendor assessments, vendor management, RFIs, RFPs. Responsible for Corporate Procurement team engagements.

PROFESSIONAL EXPERIENCE:

Proposal Solution Architect

Confidential

Responsibilities:

• Proposed Toolchain: EKS, AirFlow, AWS Glue Data Quality, Streaming Data-Pipelines, Snowflake-integrations, Matillion-integration, Kappa-architecture for Data-pipelines, Athena, Flyte (Lineage).

Lead

Confidential

Responsibilities:

• Successful kickoff of Roadmap, based on pro-active enthusiasm within specific teams vs. an App-based / tech-debt based approach.
• Defined Multi-Cloud Target-state: Azure DevSecOps platform/PaaS, toolchain, processes and CoE-based support model (incl. materials), as well as Workstation toolset (incl. SonarCube).
• Initiated collaboration with client’s Security team on choice of Scanning toolsets; a portal/registry for open items, issues and actions. All System Validation artifacts in Confluence, incl. scripts.
• Assessed impact of Azure DevSecOps on SDLC; Initiated GxP collaboration with IT QC & Business QA functions, towards customizing the specific DevSecOps model within SDLC (Pipeline-JIRA integration).
• Shift-Left mentality: changing behaviors to iterate fast, check-in code frequently, address open-issues asap, the need for replicability of issues,etc.
• Instilled security best-practices oobox, especially w.r.t. handling of secrets.
• Leveraged standardization when possible, and enabled accelerated launch of new workloads (microservices & application-components or full new projects) via OAM-like yaml-based workflows, incorporating best-practices, standards, pre-configurations and ready-to-use samples (non-containerized) onto AWS as well as onto on-premises vendor-platforms like Apigee & Tibco BW BusinessWorks.
• Cloud-native thinking, on-demand pay-as-you-go templatized environments, relentlessly increase the levels of automated testing, developer-workstation configuration (incl. local toolset), equal focus on security as well as code-quality,etc.
• Working with GSD and infrastructure re: Non-standard support for developer-workstations and software-catalog for GxP compliance of environments.
• Stand up a new AWS + Azure multi-cloud DevSecOps-capability and the first DevOps pipeline covering Azure-Git, Build and Deploy Pipelines incl. AWS DynamoDB as deployment-records database.
• DevSecOps highlight: Automatic configuration of all new Git-based projects for Asymmetric-key Encryption (PKE) of 1,000s of files across 200+ repos, containing secrets/keys/IDs; Evaluation of Mozilla-SOPS vs. git-crypt+gnupg, for a transparent error-free developer-experience, from day-1 till end-of-life. Use of RSA-2048 signed Asymmetric-Key centrally-managed s for developers.

DevOps CoE Lead, Cloud CoE Lead, Transformation Delivery Lead

Confidential

Responsibilities:

• Stand up a new DevOps service & new teams for DevOps CoE as well as AWS CoE, while consistently demonstrating that Cognizant is the premium choice for accelerated delivery on AWS.
• Accelerated Re-Platforming of solutions (completed in 3-4 weeks), via 100% DevSecOps-Automation with robust cloud-native monitoring, cloud-native secrets, while collaborating with BMS “uptime” frameworks for stringent AWS cost-controls, as well as participating in In-house Audit reviews representing Cognizant.
• Devised a robust best-practice towards maximizing public IP-CIDR efficiency of AWS accounts, via extensive use of private-subnets even for large k8s-clusters.
• Transformation proposals: highly-accelerated robust deep-dive analysis of 40+ applications completed in under a few weeks, leveraging Cognizant’s IP tools to define robust SOW effort & cost estimates.
• Pioneering effort in being the first to Re-Platform IBM Maximo v8.7 Manufacturing Asset Management COTS product (with GMP & GxP compliance) onto AWS “R O S A”, leveraging AWS MSK/Kafka, DocuDB & underlying Kubernetes, with primary objectives of cost-efficiency, IP-CIDR efficiency as well as on-demand flexibility via DevOps. Ingest data from DB2 SQL into Spark-Jobs within CloudEra CDP.

Solution Architect, Bidding Proposal

Confidential

Responsibilities:

• Re-Build and Re-Package (deployable) a SFDC/Heroku-Cloud based application to GCP/GCE (Kubernetes-cluster based design), leveraging Akamai’s CDN and supporting Search-Engine Optimization.
• Build real-time retail-app prototypes (that was demoed to client) utilizing Vue.js & Spring/Java and multi-stage Docker-builds, with production-level UI finish. Apps were deployed to GCP Kubernetes cluster.
• Team-Lead for a “horizontal” UI Engineering team that supports all “domains” (various Macy’s teams), towards a Domain-driven design, platform-choices, tools and best-practices (taking over from Macy’s SMEs)
• Defined technology-template to rewrite & modernize the Macy’s website (Backbone to Vue.js), and to upgrade integrations between dozens of front-end & REST-API microservices-based middleware systems, for a stateless and high-performance website that also supports “Experimentation” (on Consumer-behavior) and supporting both Adobe-Analytics metrics-capture and Telium.
• Primarily responsible for onboarding all new-hires onto a standardized platform and best-practices, to ensure uniformity in software-development, code-quality and developer-workstations (incl. Dockerization)
• Team member of “Digital Marketing” domain that was focused on Wallet and Loyalty-Points web-apps.

Technologies: Node.JS, Vue.js, Vuetify, Spring Boot, Spring Data, SSE/Web-Sockets, Webpack, IntelliJ, Visual Studio Code, YAML, JSON, Kubernetes (Developer), Jira, Cassandra and GCP, Docker, SonarQube on CI/CD pipeline, Enterprise NodeJS Repo, Sonatype Nexus integration with CI/CD pipeline.

Principal Solution Architect

Confidential, Princeton NJ

Responsibilities:

• Designed a secure HIPAA & PCI-compliant Confidential t-Scheduling sub-site to IntegratedGenetics.com Sales & Marketing website, enabling Confidential ts & Genetic-Counselors to interact Privately (incl. workflows and audit-trails), REST-API integrations with Google-Calendar, OpenDoc (Video-conf), Twilio. Built by 3rd party/ PWNHealth. Highly confidential “Genetics-Consult Report” was securely delivered and stored within internal system.
• Defined architecture for Integration-security and User-Accounts lifecycle mgmt. for a network-isolated dedicated-hosted "Simplicity" SaaS-based GxP-compliant offering consisting of 8 applications, for client Eli Lilly (encompassing security and integration). Delivered to client's satisfaction per their security-standards and per SOW cost-estimate. Technologies: Oracle CTMS, Clinical Risk Mgmt systems and security-integrations for User-Accounts lifecycle mgmt., SAML 2.0, TIBCO BW, API-Gateway, Axway MFT, MS-AD integration, Confluence for all artifacts.
• Authored Hosting and Integration design-proposal for AWS-hosted "Xcellerate" SaaS-based GxP-compliant offering for GSK & CSL-Behring, including secure client-integrations (both REST microservices data-flows and user-account lifecycle mgmt.) as well as Spark jobs on fixed EC2-based Hadoop clusters.
• Primary IT point-of-contact for Internal-Audit and Client-Audit engagements; Proactively took ownership of Audit remediation of IT action-items, as identified by client (Prothena) Audit. Owned all internal-to-IT coordination, to Resolve (Close) IT CAPA items to client’s satisfaction.
• Organizational behavioral-change, modernizing IT-team's work-practices and toolset without impacting regulatory compliance, to transition project-teams to use Yammer (instead of email) for Project-related collaboration efforts (like Requirements Elicitation, Q&A, Clarifications, Sample-data)
• Authored and implemented (in collaboration with Covance Vendor-Management team) a Corporate-wide template for RFP process, complementing Business-team's RFP questionnaire. Template covered Security, IT-Operations, Support handoffs, Critical Master-Data, Data Protection/Regulations, Technology & Integration-assessment, fit/gap-analysis and gap-costing
• Rolled out enterprise-wide messaging (as part of operational excellence) re: Proof-of-Concept, Pilot and Production transitions, ensuring speed via consistency, effective security, seamless user-experience and robust audit defense
• Worked with Confidential Inc. consultants to define Architecture role and responsibility towards GDPR-compliance readiness, covering both the Pre-Project Analysis (PPA) phases and Execution-phases. Helped finalize & implement “DPIA” regulatory-assessment tool for uniform use by all projects.

Sr. Solutions Architect

Confidential, Lyndhurst NJ

Responsibilities:

• Business Goals: Urgency to remain competitive via technology-supported new service offerings, enabling us to retain existing preferred-vendor relationships (client-stickiness & vendor management) while supporting growth globally through new partnerships and alliances.
• Led Business & IT teams through 6-month Strategizing, Discovery and RFP phases of a $20M initiative to replace core-lab system that is entrenched throughout all business processes.
• Designed a plan for PoC and Production-migration based on Master-Data and -data models, with plans for integration-feeding both legacy and new system simultaneously, and for new Gxp-compliant custom-tool for business-teams to easily do verification and to ensure rapid IT-Validation.
• Business Goals: To digitize and fully transform paper-based processes, enabling operational excellence, and enabling end-to-end “Specimen Tracking” and enabling superior data Quality.
• IT team lead for 9-month Discovery, Marketplace assessments & vendor/product research, RFP, Voice of Customer workshops and project kick-off
• Designed near-real-time inbound GxP-Compliant data-flow solution (sources: HL7-Orders/Reqs APIs, file-drop or EDI), towards ensuring low-impact on transactional-systems and their databases. Design augmented data-flows to capture/redirect low-quality data into a proprietary UI-based workflow solution.
• Business Goals: Business needs to effectively monitor and track operations, as well as financials. Most importantly, business needs to detect quality-issues pre-emptively before clients notice the issues. Desire to take advantage of mountains of clinical-test data to mine for subject-rich geographical areas.
• Responsible and IT-lead for the successful 12-month Discovery and the RFP phases of this $1M initiative covering Governance and Quality frameworks, while also leveraging corporate Informatica-MDM setup.
• Responsible for leading all Technology Partnerships (Vendor Management) with Microsoft, HCL, TCS, and industry-specific vendors like LabVantage and LabWare (in collaboration with Quest’s Vendor Relations & Vendor Management function)
• Was IT’s primary lead for 6-month long effort developing an 8-year (2020) technology-transformation strategy, with a single-slide message incorporating marketplace, technology, regulatory and competitive assessments
• Part of a 3-person team to translate client requests into appropriate portfolio planning items and requisite technology-investments and technology-resourcing needs
• Responsible for Information-Security Gap/ Compliance Assessments and Remediation/Risk-compensation plans. Consistently maintained a company-wide reputation for solutions with low security risk profile.
• Participant in Governance committee meetings, covering: portfolio planning and prioritization, budget impact assessments, risk assessments supporting re-prioritizations and conflict resolution

Consultant, Enterprise Architecture group

Confidential, Warren & Summit NJ

Responsibilities:

• Collaborated with Business Partners (Account Managers, Business Liaisons) on completing the Business Case, with the bulk of the Investment plan focused on a 2-yr period (incl. ROI).
• Authored an initial draft of the Maturity Gaps and Maturity Outline for a 5+ yr horizon, with Target & Transitional States (multiple alternate Roadmaps), that supported Mobile Platforms & collaboration
• Responsibility for overall Content Management and Collaboration architecture, standards, solution patterns, best practices, File Plan, Content Types, Entitlements model, etc...
• Architecture achieved the goals of flexible, dynamic and automated policy-driven platform-performance management (Scalability, DR/Business Continuity, Geographic distribution, VM throttling, Policy-driven Fault Tolerance, High Availability, Optimal sharing of compute resources)
• Initiated first draft of Governance framework containing policies and guidelines for Content Management & Entitlements mgmt, and drafted the operational model for governance.
• Developed best practices for Security Group and access management, retaining end-user empowerment for GxP-Compliant document management solution.

Consultant, Solution Architecture

Confidential, Rahway NJ

Responsibilities:

• Single-handedly led this 16-month long initiative from conception to implementation, on-schedule and on-budget, while managing a remotely located team consisting of 6 external partner direct reports.
• Delivered a robust GxP-Compliant integration-solution to bring in blinded Confidential t-data, by normalizing data from Research partners based on multiple industry-standard medical dictionaries, to feed a unified research data warehouse (CDR) to support Clinical Operations’ strategic needs. Technologies: Java, Informatica ETL, WSDL/API, JMS.
• Led the first phase of a multi-year initiative, as a Business Architect delivering a formal assessment of processes and a recommendation for Data Governance (Stabilize & Control phase)
• Led engagement with business team towards explicitly defining Business Triggers, Outcomes, Ownership as well as Metrics for identifying and measuring value delivered via the processes and individual activities
• Sole responsibility of a detailed assessment of Risks as well as Transactional & System-Integration issues associated with potential turnkey Outsourcing of key in-production GxP-Compliant applications.
• Participated in a comprehensive assessment of Global Portfolio Management function, covering all Franchise and Functional Units - ranging from Pre-Clinical to core Clinical Operations (Merck R&D Labs running Phase 2 to Phase 4 clinical studies).
• Sole author of a Roadmap proposal for a comprehensive globally-authoritative repository supported by a Governance framework towards ensuring a high level of Data Quality.
• Led effort to identify Quick Hits for Rationalization of systems and processes, along with Standardization of data (incl. Master-Data), laying the groundwork for successful subsequent phases.

Solution Architect

Confidential, E. Hanover NJ

Responsibilities:

• Was responsible for a team of 3 offshore FTE direct reports, and led multiple global initiatives supporting the core Clinical operations (Clinical Studies).
• Led projects and initiatives with team sizes ranging from 3 to 7.
• Was the IT lead for the cross-functional e-Protocol initiative (Advanced Clinical-Trial Design & Planning). The goal was to transition company's current processes based on Word-format Protocol documents, towards an 100% data-centric structured-data entry GxP-Compliant solution enabling significant efficiencies within study budgets ed Business Excellence by Business Team, for helping business achieve timely milestone progress and for defining a well-articulated long-term authoring-platform and solution strategy
• Led an innovative & acclaimed working Prototype, incorporating latest UI & Visualization technologies allowing the business team to effectively evaluate project feasibility.
• Picked as Architect for Linux-cluster based High-Performance computing needs of the Statistical Simulation and Modeling (MODSIM) initiative - Project delayed.
• Participated in multiple projects as the EA representative, responsible for articulating tactical and strategic technology choices, for individual project-level releases for applications.