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Biotechnology
Biologics, vaccines and emerging modalities, where the science moves faster than the org chart and every hire is visible on the burn rate.
The problem
The org chart says twenty people. The regulatory expectations are the same as they are for a company of two thousand. Somebody has to own quality, somebody has to own the IND, somebody has to own vendor oversight, and there is not enough headcount to give any of those roles a full-time owner with the right background.
The usual compromise is to spread it across people who are already stretched, then hire a senior lead late and expensively when a milestone forces it. That works until an investor asks to see the quality system, or a regulator asks a question nobody in the building has been asked before.
Fractional senior expertise solves this properly. A part-time head of quality who has done it three times is worth more than a full-time hire who has done it once, and costs less than the mistake you avoid.
Tell us the problem. A specialist replies, not a form robot.
What we do
Upstream and downstream processing, analytical development, characterisation and tech transfer.
Protocol design, the regulatory strategy behind it, and the documents that follow.
Part-time heads of quality, regulatory and clinical operations.
Quality and validation resource for the jump from pilot to commercial scale.
Quality systems and files that survive diligence, not just inspection.
Shortlists in 48 hours for programmes that cannot wait a quarter to hire.
1
Senior specialist, part time, beats one full-time generalist
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Questions
It changes the structure, not the standard. Contract-first arrangements keep the burn flexible, and fractional senior roles give you seniority you could not otherwise afford. We would rather build with you early than sell you a permanent search you cannot fund.
Yes, and earlier is dramatically cheaper. Diligence tends to probe quality systems, vendor oversight and data integrity. Those are fixable in advance and awkward to fix under a term sheet deadline.
Yes, and where we do not have depth we say so. Gene and cell therapy has its own page because the manufacturing and regulatory path are genuinely different rather than a variation.
Profiles inside 48 hours for most CMC and analytical roles. Genuinely scarce combinations, for example a specific modality plus a specific platform, take longer and we will tell you at intake.
Yes, and it often does once a round closes or a milestone lands. The conversion terms are agreed up front so it is not a renegotiation at the moment you most need continuity.
Related
Judge us on the shortlist, not the sales deck.