Turning a vision into a reality.

I build business plans and cases top-down and then verify bottom-up: what it will take, what it will cost to build and to run, what it has to return and by when. The numbers are checked by actually talking to prospects and business partners.

ExperienceAs COO, I owned the business plan and P&L of a new Dx business unit against a €20M programme budget, deciding what it would and would not build, on a 30%+ gross-margin base case. At a biotech, I rebuilt the company business plan from the capital and operating budgets up.

All-in cost is not just about what your CMOs charge you for raw materials, labour, facility rental and so on. It also includes the cost of testing, storing and intracompany product transfer. Understanding what customers are willing to pay requires physically approaching them and gathering market intelligence. Often neglected are the commercial terms: volume, exclusivity, quality obligations, payment terms and schedule. All of the above quietly decide whether the margin survives.

ExperienceFor an instrument and consumable business, set cost of goods and selling price together to a 30%+ gross margin. At a biotech, set sale price and cost of goods from quoted and measured costs rather than estimates, and did the same for an IVD programme. Negotiated supply and quality agreements with multinationals, and passed manufacturing site quality audits.

I highly recommend board reports with a fixed structure and narratives, and not just some static graphs with a few bullet points. I believe it would give each board member more context, and make the board meeting a more informed, focused discussion. The report should cover the company’s finances, its business, and the key topics that reflect the stage the company is at. In any case, each section should include a quantifiable risk reporting against timeline, budget and quality, each with a mitigation, an owner and a date, so the board has something to decide rather than only to note.

ExperienceA direct reporting line to the board in every COO role. Reported periodically: the operating budget against actuals, cost of goods and profit margin, inventory value, the manufacturing plan, key project progress, quality issues and customer feedback — each with its risks, the mitigation in hand, and the decision I needed the board to take.

Even when I thought we knew the process inside out, getting it into an external production facility with reliable reproducibility and quality was a completely different level. Before tech transfer, I make sure we actually know our process window: not just how to make it work, but where the limits are at which it stops working. This is then used as a blueprint for the CMOs to further develop our process within their facility.

ExperienceI have led two industrialisations with almost nothing physically in common. An integrated diagnostic platform, with the manufacturing lines for its consumables and reagents qualified. And a fermentation process from 5 and 30 L in the laboratory, through an 8 m³ pilot, to 120 m³ commercial scale.

Make or buy is a calculation, not a default. I compare the all-in internal cost against the quoted external one, including the parts that get left out: incoming inspection, release testing, storage, transport, and the working capital tied up in a minimum order quantity. Then the supplier work itself. Shortlisting the ones who actually want a volume your size, negotiating the supply agreement and the quality agreement together, and running a review often enough to hear that a batch is at risk before it is late. Outsourcing buys their lead time as well as their capacity, so production planning starts from a date you do not set.

ExperienceManaged the engineering house, software developer and contract manufacturers behind diagnostic instruments and plastic disposables, then led technology transfer with a contract manufacturer for a fermentation process. I have worked with contract manufacturers across Asia and Europe, in biotech and biologics as well as diagnostics and hardware, and run supply chain and production planning across an entirely outsourced model.

A quality system written for the audit gets you the certificate and nothing more. I build it into the processes the company already runs: document control, change control, CAPA, supplier qualification, and design history where the product needs one. The procedures are drafted in the words the team already uses, by the people who do the work, so the system is followed between audits and not only before them. ISO 9001 or ISO 13485, depending on what you sell.

ExperienceISO 13485 achieved at an IVD platform company, and its scope later extended to cover instrument hardware and software at a molecular diagnostics group. ISO 9001:2015 achieved at an instrument start-up. At a biotech, quality built as an internal function rather than bought in.

One set of objectives for the year, ranked, and cascaded to team level so everybody can name the ones they own. Ranking is the part that gets skipped, and it is the part that decides what gets dropped when the quarter is short. Each objective needs a measure, a name against it and a deadline, written somewhere everybody can see. Then the meeting rhythm that keeps them current: a short weekly on the measures and the blockers, and a quarterly to review what was delivered and set the next period.

ExperienceIntroduced OKRs and EOS as the working method, aligned the company objectives and cascaded them to each team. Ran the routine meetings that review the measures, clear roadblocks and re-cut the plan, and built the dashboard that made all of it visible across teams.

Agreed before the work starts: the deliverables, the dates, the owner and the budget. Then phase gates, with the criteria written in advance, where no is a permitted answer. The gate is worth more than the plan. A project nobody can stop keeps consuming people and budget long after the reason for it has gone, and that cost never appears in any report.

ExperienceI have run every company this way, and I have used the gates to stop things: an external engineering partner halted mid-programme, where the objectives and the governance had never been agreed, and the work restarted with another; and research with no commercial outlook, so the team could finish what the market was actually asking for.

Who owns what, who decides what, and what everybody else can expect from them. I write this down before the hiring rather than after the frustration: an organisation chart, a short accountability for each role, and the decisions that role can take on its own. Most of the friction I am asked to fix is not between people. It is two roles that were never told which of them decides.

ExperienceAt a start-up of around 25 people, built R&D, manufacturing, quality and customer service with field servicing, 15 of them reporting to me. At a molecular diagnostics group, added project management, systems engineering and HR past 40. At a biotech, redefined roles and responsibilities, brought quality in-house and appointed an HR director.