About

Dr Jerome Keldenich

I have spent twenty years in pharmaceutical development and sterile manufacturing, and I have spent them on both sides of the table — inside contract manufacturers delivering for clients, and inside sponsors buying from them. That is the perspective I bring to a mission: I know what the other party is worried about.

The work divides roughly in two. On the development side, ten years of CMC for medicinal products — drug substance and drug product, clinical trial material, scale-up and technology transfer — including running CMC for a clinical-stage sponsor taking oral immunology therapies through late-phase development. On the manufacturing side, fifteen years of aseptic processing, much of it with highly potent compounds and cytotoxics, and the commissioning and qualification that brings a sterile facility into use.

Freeze-drying runs through both. It is where I have specialised, where I publish and present, and what most clients call me about first.

Background

• Since 2024

  Founder of Pharma K Consulting SRL. Independent consulting and training in lyophilization, aseptic manufacturing, C&Q and CMC.

• 2021–2024

  Chief Scientific Officer and MSAT Director at the Cenexi Group, across Belgium and France. Fifteen direct reports spanning process engineering, pharmaceutical and analytical development, regulatory affairs, business development and project management — a group of a hundred and twenty people across four sites.

• 2019–2021

  Head of CMC at Immunic Therapeutics in Munich, developing oral immunology therapies for chronic inflammatory and autoimmune disease through to commercial launch preparation.

• 2015–2019

  Programme and technology transfer management at Lonza/Capsugel, Patheon (part of Thermo Fisher Scientific) and Takeda — lipid-based formulations, oral solids including highly potent compounds, and global CMC programmes across Europe, the United States and Japan.

• 2011–2015

  Pharmaceutical Development Director (ad interim) and senior project manager in sterile product development at Cenexi Laboratoires Thissen in Belgium, including the GMP certification of a sterile products development centre.

• Earlier

  Medicinal chemist at Axon Medchem in the Netherlands, then principal scientist at Baxter R&D Europe in Belgium.

Education and affiliations

PhD in organic and macromolecular chemistry, awarded with honours in 2006 in collaboration with Sanofi-Aventis and the Laboratoire de Catalyse de Lille, followed by a Marie Curie post-doctoral fellowship in biophysics. Earlier degrees in chemical engineering, drug design and organic chemistry from Lille.

Six Sigma Green Belt. Member of the Parenteral Drug Association and of the International Society of Lyophilization – Freeze Drying. Co-inventor on an international patent covering assembly and filling for needle-free medical devices, and author or co-author of publications in asymmetric catalysis and, more recently, in lyophilization.

How I work

• Inside your system

  Your templates, your document numbering, your QA reviewers. A deliverable that cannot be approved through your own quality system is not a deliverable.

• Scoped before started

  A defined deliverable and a date, agreed before the first day. If the scope turns out to be wrong, I say so early rather than quietly extending.

• Handover as a deliverable

  The point is that your team can maintain and defend the file after I leave, not that they need me again next year.

Where I work

French is my mother tongue and I work fluently in English. I have good passive German and basic Dutch. Engagements are on site or hybrid, and I have worked on global programmes spanning Europe, the United States and Japan.

Countries where Pharma K Consulting has extended its network of influence since its creation in 2024.

The company

Pharma K Consulting SRL is registered in Belgium and invoices from there. Contracts are normally direct with the client, or through a staffing intermediary where the client requires it.

Registered office: Avenue des Tarins 25 B, 1950 Kraainem, Belgium.
VAT and enterprise number: BE 1014.282.676.