Ravi Samavedam
CCO, Partner
Ravi brings 25+ years of experience, from leadership roles at Baxter, Amgen, and Shire to building Azzur’s consulting arm and co-founding Cleanrooms on Demand. He’s an expert in cGMP strategy, build vs. buy analysis, supplier management, launch planning, and process validation.
Shaleen Parekh
COO/CFO, Partner
Shaleen brings 25+ years in biopharma, specializing in cGMP quality, process validation, and continuous improvement. A former Head of Quality and successful entrepreneur, he’s held multiple C-suite roles and advises companies on operations, quality, and talent development strategies.
Scott Corbin
President, Partner
Scott brings 35+ years of experience in facility design, operations, quality, and validation, with leadership roles at Genzyme, Lonza, and Azzur Group. As an ASQ and ISO 13485 certified auditor, he’s a recognized expert in building compliant, high-performing biopharma facilities.
Dave Manku
CEO, Partner
Dave brings 30+ years of experience in pharma manufacturing and engineering, with deep expertise in facility design, expansion, validation, and cGMP compliance. He’s led projects from startup through routine operations, streamlining quality systems and leveraging risk-based approaches to cut costs and minimize regulatory risk.
Jackie Lafrance
VP of Quality
With 28+ years of experience in operations and quality leadership, Jacki LaFrance is a trusted GxP consultant and transformational partner for life-science organizations. She drives system improvements, supports scalable growth, and ensures regulatory excellence. She is known for building high-performance teams and harmonizing strategy with execution.
Michael Green
Practice Leader, East Coast
Mike oversees East Coast operations, bringing 20+ years of expertise in life sciences manufacturing, facilities, and operations. He’s led GMP site startups, scale-ups, and transformations at Vizgen, Quanterix, Agilent, and Sanofi, using Lean manufacturing and continuous improvement to drive growth and operational excellence.
Matt Hoffman
Practice Leader, West Coast
Matt has 17 years of experience in equipment, process, CIP, and automation CQV, specializing in risk-based commissioning and validation of complex super skid systems. He leads projects from design and FAT through commercial readiness, emphasizing quality integration early in engineering to ensure efficient, compliant execution.
Brittany Carlstedt
Director of Operations
Brittany is an operations leader with over a decade of experience in the life sciences industry. She drives strategic initiatives at GrayMatter Partners, optimizing processes, enhancing organizational performance, and enabling sustainable growth and success.
David Grote
VP of Strategy
David Grote is a biopharma executive and strategic advisor with 25+ years of experience. David transforms quality and regulatory compliance into a commercial advantage, driving growth, accelerating approvals, and de-risking supply chains. His experience includes leading FDA remediation efforts, implementing AI-driven quality tools, and directing strategies that have supported over $1B in annual revenue helping executive teams turn quality into a key driver of business value.
Ashkan Khalili
Senior Consultant
Ashkan is a seasoned Chemical Engineer specializing in facilitating new cleanroom construction and developing adequate cleanroom certification programs. He is also adept in CQV of critical utilities and equipment, including HVAC, purified water and gas systems, BMS, and ISO 14644 GMP compliance.
Daniel Skypeck
Senior Consultant
With 20 years of experience in biotech, Dan drives GMP Quality System implementation and alignment with operations to achieve compliant, efficient outcomes. His phase-appropriate QMS strategies and ASQ-aligned mindset ensure operational excellence and business and quality focused decision-making.
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