Freeze-drying is where sterile projects start to slip.
Independent consulting in commissioning, qualification and validation for sterile manufacturing — with a specialism in lyophilization, where the cycle, the equipment and the regulatory file all have to agree.
Every argument you make to an inspector about a freeze-dried product comes back to this curve — and to whether you can show the same curve is delivered by every dryer on the floor.
What I do
Twenty years in pharmaceutical development and sterile manufacturing, on both sides of the table — inside CDMOs delivering for clients, and inside sponsors buying from them. I work as an independent consultant, leading a workstream end to end or covering a role while your own team is stretched.
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Lyophilization
Cycle development and qualification under QbD and QRM, performance equivalence between dryers, transfer between units and sites, and the container closure decisions that change what a cycle can do.
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Commissioning and qualification
URS through IQ, OQ and PQ for filling lines, isolators and freeze-dryers — including cleaning and sterilization validation for CIP and SIP equipment. I have run C&Q teams on projects at the largest capital scale in this industry.
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Aseptic processing and Annex 1
Contamination control strategy, aseptic process design, and containment for highly potent compounds and cytotoxics, where cross-contamination governs the whole facility layout.
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CMC and pharmaceutical development
Formulation and process development from early phase to commercial, scale-up, process validation and continued process verification, for injectables, lyophilisates, pre-filled syringes and oral solid dosage.
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Technology transfer
Moving products and processes between sites, between scales, and between organisations — with the risk analysis, the technical package and, where needed, the contractual frame around it.
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QbD, risk management and training
Embedding Quality by Design and quality risk management as something a team actually uses. I co-authored a global QbD policy for a top-twenty pharmaceutical company, and I train as well as implement.
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Interim management and mission cover
Freelance cover as C&Q manager, qualification or validation lead, or development lead, on a defined mission. Most recently as ad interim Fill and Finish C&Q manager leading a team of eight engineers.
Selected work
Recent missions under Pharma K Consulting. Client names are withheld unless I have written permission to use them.
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Fill and finish C&Q leadership
Ad interim C&Q manager for the fill and finish scope of a major greenfield sterile facility, leading eight C&Q engineers across three isolator filling lines.
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Two aseptic lines, delivered
C&Q coordinator responsible for delivering two lines for aseptic manufacture of sterile drug product including lyophilisates, with the cleaning and sterilization validation for complex CIP and SIP equipment.
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Batch to continuous manufacturing
Conversion of a coated tablet in three strengths from batch to continuous manufacture between Phase 2 and Phase 3, for a chronic disease treatment.
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New closure paradigm in freeze-drying
Subject matter expert and trainer on the shift to plastic press-fit closures — characterising the effect on primary drying efficiency and on in-chamber capping. Presented in Geneva in 2026, with a white paper to follow.
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Continuous drug substance by flow chemistry
Supporting an SME in building continuous small-molecule drug substance capability to a standard suitable for a GMP aseptic environment.
Start a conversation
If you have a qualification problem, a cycle that will not transfer, a process that has to move, or a mission to fill, tell me what the deadline is and I will tell you honestly whether I can help.