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Executive Search · Technical Operations

Biopharma Technical Operations Executive Search.

Retained, partner-led search for the leaders who run the plant, the network and the schedule: Chief Technical Operations Officers, EVP and SVP Technical Operations, and the manufacturing, MSAT and supply chain heads beneath them, calibrated to stage, modality and manufacturing model.

112+
CMC, Quality & operations placements
62.6%
of published FDA CRLs carry a manufacturing or quality deficiency
13
years, life-sciences technical leadership
Technical operations leaders reviewing a biomanufacturing floor (illustrative)
The Argument

Technical Operations is where approval becomes supply.

The Data
62.6% of the FDA’s published Complete Response Letters (286 of 457) carry a manufacturing or quality deficiency section, and biologics run higher still at 68.9%. The risk that stops an approval is operational. It lives in the plant, the external network and the batch record: the Technical Operations mandate.

Source: Phase 3 Search analysis of the FDA’s full published CRL archive, July 2026 (The Complete Response Letter Report); triangulated by Jefferies’ read of the same archive, May 2026. Method and sensitivity checks: methodology.

For the CEO, the stake is runway: a manufacturing-driven Complete Response Letter sets a program back a median of 1.28 to 2.5 years (RSM US LLP; Therapeutic Innovation & Regulatory Science, 2026), and that delay is refinanced on the worst terms a company will ever see. For the technical leader, it is the difference between a process that worked once and a network that works every time. For the Head of Talent, it is the seat most often hired late, on a brief written for the last stage rather than the next one. In the language of the CTO Mandate Framework, Technical Operations carries two of the five promises: Scalable and Durable. We search against them.

Roles We Place

The operating layer, seat by seat.

01
Chief Technical Operations Officer / EVP Technical OperationsExecution at enterprise scale: plants, external networks, cost of goods, and the supply promise made to the board.
02
SVP / VP Technical OperationsThe operating cadence from clinical supply through launch: schedule, capacity, tech transfer and the CDMO relationships that carry them.
03
VP Manufacturing / Site Head / Plant General ManagerInspection-ready operations inside the fence: people, batches, deviations and the record an investigator reads.
04
VP External Manufacturing & CDMO ManagementThe network as a system: partner selection, governance, capacity reservation and the second source before it is needed.
05
Head of MSAT / Process EngineeringThe bridge between development and the plant: tech transfer, process performance qualification and continued process verification.
06
VP Supply Chain & Clinical SupplyDemand, inventory and logistics for investigational and commercial product, including cold chain and the shortage plan nobody wants to use.
When to Hire

The job changes with the manufacturing model.

The same title hides three different jobs. We calibrate which one you are hiring before we open the market.

Phase 1–2 · CDMO-led

The first operations leader

Clinical supply through an external network, comparability groundwork, and the make-or-buy decision that will shape cost of goods for a decade. Often a VP with CDMO fluency rather than a plant builder. We advise when the full seat is premature, and what to hire instead.

Phase 3 → Launch

The commercial-readiness operator

Process performance qualification, pre-approval inspection readiness, dual-sourced supply and a launch plan that survives its first deviation. The seat that decides whether an approval converts to product on shelves.

Commercial · Multi-site

The network leader

Tech transfer across sites, onshoring and capacity decisions, cost of goods under pricing pressure, and continuity when a partner site draws a Form 483. The operator who runs a system, not a plant.

Case in Point · Placements & Partnerships

Operations leadership placed where the batch record matters.

Placements and partnerships across Alnylam, BioMarin, Boehringer Ingelheim, Bristol Myers Squibb, Gilead, KBI Biopharma, Nitto Avecia, Spark Therapeutics and Vertex, spanning sponsor technical operations and the CDMO side of the network. Companies we have placed into have since exited for an aggregate of over $7.3Bn, and Phase 3-placed leaders have helped move 125+ assets toward launch.

“The best search experience I have had in my whole career. The successful candidate has been exceptional.”
Tim Maines · CTO Quality, Alnylam Pharmaceuticals
How We Search

Diagnostic first, then the market.

Every Technical Operations search begins with the mandate read: which of the five mandates the next two years actually demand, with particular weight on Scalable and Durable, what the current organisation can already hold, and where the gap is structural rather than personal. Then a partner runs the market end to end, through the CMC, Technical Operations and Quality networks we have worked for 13 years, not a résumé database. You get a calibrated slate, a written read-back of what we heard, and a recommendation that may be “not search”.

Questions

Technical Operations executive search, in plain terms.

What does a biopharma Technical Operations leader own?

The plant, the network and the schedule: internal manufacturing, the CDMO relationships, MSAT and tech transfer, supply chain and clinical supply, and the batch record that goes in front of an inspector. In the CTO Mandate Framework, Technical Operations carries the Scalable and Durable mandates: making the platform real and keeping supply secure under stress.

What is the difference between a CTO and a Chief Technical Operations Officer?

The CTO owns the whole technical enterprise, from process development through manufacturing and the interface with Quality and Regulatory. The Chief Technical Operations Officer owns execution at scale: plants, external networks, cost of goods and supply continuity. Early companies combine the two seats; from Phase 3 onward, most separate them.

When should a biotech hire a VP of Technical Operations?

When manufacturing decisions start locking in cost and comparability, usually as a program approaches its pivotal study. Before that, a strong VP of CMC with a well-managed CDMO network is often enough. Advanced modalities such as cell and gene therapy need the seat earlier, because the process is the product.

Do you place Technical Operations leaders into CDMOs as well as sponsors?

Yes. Site heads, general managers, heads of manufacturing and MSAT for contract development and manufacturing organisations are a core part of the practice, and CDMO experience is one of the most compressed operator training grounds in CMC. See our dedicated CDMO executive search page for that side of the market.

How does Phase 3 run a Technical Operations search?

Diagnostic first. We read the company against the five mandates of the CTO Mandate Framework, with particular weight on Scalable and Durable, agree with the board what the next two years demand, and only then build the market map. A partner runs the search end to end through the CMC, Technical Operations and Quality networks we have worked for 13 years.

From the series

Operations leadership, in depth.

What the plant builds in a leader, where CDMO decisions actually live, and the two mandates Technical Operations carries.

Made Under PressureWhy a CDMO leader carries an operator’s training the sponsor side rarely gets.
Where CDMO Decisions Actually LiveWhose head the answer lives in when the network is the plant.
Scaling: The Hole in the MiddleThe operations layer companies forget to build between development and launch.
When to Hire CMC Leadership in BiotechSequencing the technical hires, and defending them to a board counting every dollar.
Mandate 4: ScalableA platform is a claim. The machine makes it true.
Mandate 5: DurableSecurity of supply under inspection, shortage and stress.
Start Here

Run the diagnostic on your next hire.

Thirty minutes. A structured read on the role. We tell you whether search is the right product, whether the brief reflects the company you are actually inheriting, and whether the leadership architecture sits where it needs to be for your next capital event.