OVERVIEW
FOCUS AREAS
12+ years of leadership in engineering, CQV, and project management across life sciences.
Capital project execution
CQV strategy and implementation
GMP compliance and risk management
Biotech facility startup and readiness
Client advisory and team leadership
Maulik Patel leads consulting operations of New England region with a focus on delivering high-impact solutions across the life sciences sector. With over a decade of experience in CQV, engineering, and project management, he is known for driving operational excellence from R&D to commercialization.
Maulik brings 12+ years of expertise across engineering operations, project management, CMC and CQV within GMP-regulated environments. His background spans biotech, biopharma, and advanced therapies, with a proven track record of executing capital and technical projects aligned with global regulatory standards.
At ELIQUENT, he oversees consulting engagements that help clients navigate complex quality and compliance challenges across product lifecycle phases. His leadership emphasizes strategic planning, risk-based validation, and lean implementation of phase-appropriate GMP systems. Prior to ELIQUENT, Maulik held leadership roles supporting multimillion-dollar initiatives for clinical and commercial manufacturing at top-tier biotech firms.
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EDUCATION:
Master of Science in Biomedical Engineering & Biotechnology, University of Massachusetts
CERTIFICATIONS:
Professional Education Program in Artificial Intelligence and Machine Learning, Massachusetts Institute of Technology (MIT)
ASSOCIATIONS:
International Society for Pharmaceutical Engineering (IPSE), Member, 2016–Present
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Director of Consulting, Azzur Group / ELIQUENT (2023–Present)
Associate Director of Program and Portfolio Management, ElevateBio (2022–2023)
Senior Manager of Operations, Project Manager, Azzur Group (2018–2022)
- Phase-appropriate GMP implementation for gene therapy, cell therapy, mRNA, and microbiome platforms.
- Capital project leadership for cleanroom, sterile operations, and manufacturing facility expansions.
- Tech transfer management for clinical and commercial manufacturing
- Validation master planning, equipment URS/FUSE development, and classified area qualification (ISO 14644)Risk assessment and mitigation (FMEA, HAZOP); regulatory compliance (FDA, EU, ISO 13485)
- Development of AI-enhanced operating philosophies for single-use manufacturing and automation
- Skilled in project budgeting, resource allocation, and decision-making frameworks using AI/ML tools
Thought Leadership:
Material Sourcing and Traceability of Origin in Cell and Gene Therapy: A Regulatory Perspective
Content Type: Written: Article
Content Source: Medium.com
URL:https://medium.com/@mmp3071/material-sourcing-and-traceability-of-origin-in-cell-and-gene-therapy-a-regulatory-perspective-92a4add79618
Date Published: January 2, 2025Optimizing Biotech Production: The Role of Artificial Intelligence and Innovative Strategies
Content Type: Written: Article
Content Source: Medium.com
URL: https://medium.com/@mmp3071/optimizing-biotech-production-the-role-of-artificial-intelligence-and-innovative-strategies-bcdac4175482
Date Published: August 28, 2024The Role of Cloud Computing in Modern Genomics
Content Type: Written: Article
Content Source: Medium.com
URL:https://medium.com/@mmp3071/genomic-data-repositories-89e2d28735d4
Date Published: July 29, 2024The Role of Big Data in Personalized Medicine and Autologous Therapies
Content Type: Written: Article
Content Source: Medium.com
URL: https://medium.com/@mmp3071/the-role-of-big-data-in-personalized-medicine-and-autologous-therapies-12408ea71dc4
Date Published: January 19, 2024
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