S. Lira Mishra
Boxford,MA
Summary
Seasoned IT leader with 20+ years in regulated life-sciences IT delivering enterprise laboratory and CMC Development solutions (Development Biologics, Development Pharmaceuticals, Devices, and Manufacturing Sciences). Deep experience partnering with Quality Control, QA and CMC Development functions to translate business strategy into technology roadmaps, business cases, validated delivery, steady-state support, and measurable outcomes. Proven at leading large, cross-functional teams and external systems integrators to deliver LIMS, ELN, CDS, instrument integrations and QA systems on schedule, on budget, and audit-ready.
Overview
12
12
years of professional experience
1
1
Certification
Work History
IT Associate Director, Laboratory Systems & PO&T IT
Biogen, Inc.
Cambridge, MA
10.2014 - Current
- Leadership, Strategy & Stakeholder Engagement
- Lead IT strategy and roadmap development for Laboratory & CMC Development (Development Biologics, Development Pharmaceuticals, Devices, Manufacturing Sciences) in partnership with QC, QA and CMC stakeholders; translate scientific and regulatory priorities into prioritized technology demand and measurable KPIs.
- Drive executive engagement (VP/IC-level) to align IT portfolio with business objectives, presenting business cases, cost/benefit analyses, and delivery roadmaps.
- Integrated enabling IT roadmaps (infrastructure, data, security) with functional demand to ensure platform sustainability, scalability and regulatory compliance.
- Portfolio Delivery & Validation
- Directed end-to-end delivery of 20+ enterprise GxP system implementations (LIMS, ELN, CDS, analytical/instrument systems, QA systems), including discovery, business case, validation (CSV/CSA), and handover to steady-state support.
- Managed cross-functional delivery teams and multiple vendors/SIs to ensure projects met schedule, scope, budget and quality targets; reduced validation cycle times by 15–20%.
- Established governance and lifecycle processes to ensure 24/7 availability of critical lab systems, achieving 100% audit readiness during regulatory inspections.
- Vendor, SI & Contract Management
- Proactively managed relationships with large SI partners and third-party vendors; negotiated contracts, SOWs and SLAs to ensure accountability and value realization.
- Reduced external vendor dependency ~30% by building internal capability centers and rebalancing SIs versus in-house delivery.
- Team Building & Operations
- Built and scaled global capability center (India) and international teams (30+ FTEs/contractors) supporting Laboratory Systems, CSV/CSA and IT Quality; improved onboarding velocity by 25% and delivery consistency.
- Led multi-site support model ensuring compliant, sustainable operations across Development Biologics, Development Pharmaceuticals, Devices, and Manufacturing Sciences labs.
- Data Governance & Cybersecurity
- Implemented enterprise data governance framework for GxP systems; defined data ownership, lineage and quality standards, reducing data-related deviations by ~20%.
- Directed laboratory cybersecurity and risk mitigation for instrument integrations and cloud/edge architectures, reducing critical vulnerabilities by ~40%.
- Earlier Roles — Biogen (Weston, Cambridge, Netherlands, Denmark) Oct 2002 – Oct 2014
Education
M.S. - Biochemistry/Biophysics
Rensselaer Polytechnic Institute
B.S. - Biochemistry/Biophysics & Psychology
Rensselaer Polytechnic Institute
Skills
- IT Leadership
- Laboratory & CMC Development IT (Development Biologics, Development Pharmaceuticals, Devices, Manufacturing Sciences)
- Quality Control / QA Partnership
- GxP Software Validation (CSV/CSA)
- 21 CFR Part 11 / Annex 11
- LIMS, ELN, CDS, SDMS
- Instrument Integration
- System Availability / Scalability
- Roadmap & Portfolio Management
- Business Case / ROI Development
- Vendor & SI Management
- Contract Negotiation
- Budgeting & Financial Oversight
- Data Integrity (ALCOA)
- Risk Management & Cybersecurity
- Regulatory Inspection Readiness
Accomplishments
- Delivered 20+ validated laboratory and QA systems supporting QC and CMC Development operations across Biologics, Pharmaceuticals, Devices, and Manufacturing Sciences.
- Built and scaled global IT teams (30+), established capability center, and reduced vendor reliance by ~30%.
- Maintained 100% inspection readiness across GxP systems; improved data integrity and reduced vulnerabilities significantly.
- Achieved $3.5M+ in cost savings through process redesign and portfolio optimization.
Certification
GMP/GCP/GLP, FDA 21 CFR Part 11 & Annex 11, Six Sigma Green Belt, Project Management Certification
Timeline
IT Associate Director, Laboratory Systems & PO&T IT
Biogen, Inc.
10.2014 - Current
B.S. - Biochemistry/Biophysics & Psychology
Rensselaer Polytechnic Institute
M.S. - Biochemistry/Biophysics
Rensselaer Polytechnic Institute
TAILORED HIGHLIGHTS FOR THIS ROLE
- 12+ years supporting QA/QC and laboratory operations in regulated environments with extensive CSV/CSA experience across Development Biologics, Development Pharmaceuticals, Devices, and Manufacturing Sciences.
- Demonstrated success leading discovery, business case development, and delivery of complex, enterprise laboratory portfolios.
- Proven ability to build credibility with senior stakeholders, integrate enabling IT roadmaps, manage large SIs, negotiate contracts, and deliver compliant, scalable technology platforms that support CMC and QC objectives.