Built for Capital Projects That Can’t Afford to Miss

Agile Advisors was founded to serve one mission: helping life science manufacturers reach operational readiness—on time, within budget, and inspection-ready. Our team brings decades of experience leading pharmaceutical capital projects across sterile manufacturing, biologics, OSD, and clinical GMP environments.

We operate with the same discipline and precision our clients demand of their own operations. Every service we provide is built to reduce risk, strengthen execution, and deliver production-ready outcomes that hold up under regulatory scrutiny.

Who We Serve

We support capital projects

Pharmaceutical manufacturers (OSD, sterile, biologics, cell/gene therapy)

CDMOs and clinical GMP manufacturing sites

QC laboratories and R&D cleanroom environments

Our experience spans greenfield builds, aseptic line installations, multi-phase retrofits, and tech transfer-driven upgrades. For facility types and sector breakdowns, see Industries We Support.

How We Work

Our delivery model is grounded in three principles:

Owner-Side Alignment: We operate as your representative—not the contractor’s. See how in Owner’s Project Manager (OPM).

Execution Discipline: We embed senior leadership, drive project cadence, and own results. More in Program & Project Management.

Compliance Integration: We ensure decisions support audit readiness, not just construction completion. Learn more in cGMP Compliance & Operational Readiness.

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Credentials That Back the Work

Our team includes certified Project Management Professionals (PMPs) with extensive experience

FDA, EMA, and global cGMP frameworks

Commissioning, Qualification, and Validation (CQV)

ISPE, ASME, PMI, and ISN standards and best practices

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Leadership Team

Agile Advisors is led by seasoned professionals with decades of experience delivering capital projects in regulated pharmaceutical environments. Our leadership team combines engineering depth, regulatory fluency, and owner-side insight to guide complex initiatives from concept through qualification.

Every leader at Agile has managed projects under real pressure—whether delivering on aggressive timelines, resolving high-impact deviations, or leading multi-vendor teams through CQV. Their backgrounds span sterile fill/finish, biologics, OSD, and clinical GMP programs across both emerging CDMOs and top-tier pharmaceutical manufacturers.

Recent engagements include:

Leading the qualification and tech transfer of five aseptic filling lines across $300M+ in capital investment
Acting as interim program leadership during the recovery of a failing $100M facility expansion under FDA oversight
Supporting operational readiness and inspection prep for new product introduction into a $200M clinical-scale site

Our leadership team remains directly involved in every engagement—ensuring technical decisions align with your business, compliance, and operational goals.

Carl Johnson

President

Brian Jenkins

Senior Vice President

John Hartman

Chief Operations Officer

Jill Ziegra

Director of Northeast Operations

What Our Clients Say

Global Expansion Program - Owner's Project Management (Large Pharma)

"Agile Advisors brought structure and clarity to a highly complex facility expansion. Their team coordinated across design, construction, CQV, and compliance stakeholders while always keeping our project goals front and center. They understood the nuances of regulated environments and consistently advocated for what was best for our operation. Their presence raised the bar for the entire program."