Integrated BioOps Group
CMC AND TECHNICAL OPERATIONS CONSULTING
Turning manufacturing
complexity into reliable supply.
We deliver strategic CMC and Technical Operations advisory for biotech leadership teams. We help companies make critical product, development, manufacturing, and investment decisions from early development through commercialization.
30 Years
Global manufacturing and CMC
leadership
Biologics
And vaccine manufacturing expertise
Large Pharma
To emerging biotech
Global
External manufacturing networks
Our approach combines deep technical expertise with executive-level perspective. We help companies make better decisions earlier, build the right capabilities, and reduce technical and operational risk as programs advance.
OUR SERVICES
Where we help
We provide six areas of engagement, from early platform strategy through commercial-stage manufacturing oversight.
Product and Platform Strategy
CMC-informed product and portfolio strategy from platform selection through development and commercialization.
Platform and modality assessment
Manufacturability-informed target and indication selection
Portfolio prioritization and lifecycle management planning
Device design and development
Technical input for licensing and asset-acquisition strategy
CMC & Manufacturing Strategy
Integrated CMC and operational strategy — from control strategy and regulatory readiness through process scale-up, technology transfer, and supply chain — aligned with clinical, regulatory, and business objectives.
IND-enabling and phase-appropriate CMC strategy
Control strategy development and regulatory CMC readiness
Manufacturing network strategy
Process scale-up and production readiness
Supply chain strategy and risk management
Commercial CMC and launch readiness planning
Organizational Design and Build-Out
Building the CMC and Technical Operations infrastructure to match company stage and strategy.
CMC and Technical Operations organizational design
Build-versus-buy and outsourcing strategy
Role definition and hiring support
Internal/external capability mapping
Organizational scaling across clinical and commercial
CDMO Strategy and Management
Strategic and hands-on leadership across the external manufacturing lifecycle.
CDMO sourcing, due diligence, and RFP/bid evaluation
Technical and operational assessments
Contracting and negotiation support
Governance model development
Performance management and escalation
Interim & Fractional CMC Leadership
Experienced executive-level leadership during periods of growth, transition, or organizational build-out.
Fractional Head of CMC/Tech Ops Leadership
Investor and board support
Cross-functional program leadership
Hands-on team mentorship and capability building
CDMO and vendor oversight during transition
Investor & Technical Diligence
Independent technical and operational diligence for investors and biotech leadership teams.
Technical and CMC diligence
Manufacturing and CDMO risk evaluation
Development feasibility assessment
Organizational and operational readiness reviews
Gap and risk analyses
Assess
We start with a focused evaluation of your technical, manufacturing, and organizational landscape, identifying what's working, what isn't, and where the risk actually sits.
Strategize
We build a phase-appropriate CMC and Technical Operations roadmap, aligned to your clinical timeline, regulatory path, and business objectives.
Execute
We stay engaged through execution, whether as an advisor, an interim leader, or an extension of your team, until the plan is delivering results.
HOW WE WORK
A disciplined, three-phase engagement
Every engagement is scoped to the problem in front of you, but the approach stays consistent.
Erik Lemay
Founder, Integrated BioOps Group
ABOUT
30 years leading biologics and vaccine manufacturing, from development to commercial supply
I've led global manufacturing and external operations across large pharma and emerging biotech environments, overseeing technology transfers, PPQ and validation programs, large-scale network expansions, and commercial product launches. My approach blends disciplined governance with collaboration, aligning technical, quality, and business stakeholders so organizations can move faster and operate with greater confidence.
Over the past several years, my role has evolved from functional leadership into broader enterprise responsibility, shaping network strategy, guiding make-vs-buy decisions, supporting BD/M&A diligence, and aligning manufacturing capabilities to long-term portfolio and business objectives. Integrated BioOps Group is where that experience becomes available to companies who need it most: small, early-stage biotechs bringing a molecule through late-stage development and commercialization, often for the first time.
PRIOR LEADERSHIP
Avidity Biosciences, Servier,
Bristol-Myers Squibb, Pfizer, Bayer Diagnostics
EDUCATION
MBA, Southern New Hampshire University
FOCUS AREAS
Biologics and vaccines, external manufacturing, CDMO governance
EDUCATION
BA Biochemistry, Ithaca College
GET IN TOUCH
Let's talk about your program
Tell us a bit about where you are and what you're working through. We'll follow up to find time that works.
Phone
978.761.3334
Prefer email? Reach out directly at erik@integratedbioops.com
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Integrated BioOps Group
CMC AND TECHNICAL OPERATIONS CONSULTING
Strategic CMC and Technical Operations advisory for biotech leadership teams, from early development through commercialization.