Pharma & Biotech Manufacturing
Complex pharma manufacturing projects, delivered.
Interim project management, validation, manufacturing planning and AI-enabled data analysis for pharmaceutical and biotech manufacturers. From someone who has led the capital projects and worked the GMP shop floor.
DKK 400M+
Capacity expansion project led in a regulated, matrixed environment
+50%
Production capacity enabled through new tank units and process optimisation
200
Craftsmen coordinated at peak, alongside a 25+ person core team
GMP
Hands-on, from upstream mammalian manufacturing to factory-scale CapEx
Services
How I can help
Capital Projects, C&Q & Validation
Your capacity project needs an experienced lead, or it is drifting on schedule, budget or qualification.
- Interim project management from scope and funding through execution, with schedule, budget and risk under control
- Commissioning, qualification and PPQ: planning the campaign, writing protocols and reports, and closing the prerequisites that keep batches on schedule
- Steering committee materials, portfolio reporting and funding requests that lead to decisions
Manufacturing Planning & Capacity
Demand is growing, but the plan does not match what the floor can deliver.
- Production scheduling and resource planning in GMP environments
- Capacity assessments that show where the real constraints are
- Realistic plans that production, QA and support functions can actually follow
AI-Enabled Analysis & Automation
You have the data in MES, SAP, schedules and logs, but not the overview.
- Highly detailed operational data turned into simple roadmaps and decision overviews
- Bottleneck identification across equipment, people and process steps
- Automated reporting that replaces manual spreadsheet work, set up within your data policies and GxP expectations
How I use AI
Automation is earned, not assumed
Every task an AI tool takes on starts as a draft that a person approves. It only runs on its own once it has proven itself on your own data, and decisions with GMP impact never leave people’s hands.
01
Draft
The tool prepares the work: an analysis, a report, a draft. A person approves or corrects every result, and every decision is logged.
02
Automatic
Once a task meets accuracy criteria agreed upfront, measured on your own data and approved by the process owner, it runs on its own with spot checks. It can be switched back to draft at any time.
03
Always human
Batch release, deviation classification, GxP records and other quality decisions stay with people. The tool can prepare them, never decide them.
Klentz ATLAS is the platform these tools are built on: one AI core, an agent for each task, and guardrails that keep people in charge.
Why work with me
I have been on both sides: the shop floor and the steering committee.
Shop floor and steering committee
I have written batch documentation, handled deviations and implemented CAPAs, and I have prepared steering group decisions for multi-hundred-million projects.
Structured, data-driven decisions
A scientific background (MSc Human Biology) and systematic A3 problem solving mean recommendations are built on evidence, not opinion.
Modern tools, used responsibly
I use AI daily to get from complex planning data to a clear overview faster, always within the client’s approved tools and data rules.
Experience from Novo Nordisk · AGC Biologics · University of Copenhagen
Process
How we get started
01
A 30-minute call
You describe the challenge. I tell you honestly whether I am the right fit.
02
A short proposal
Clear scope, deliverables and timeline, so you know exactly what you are getting.
03
Delivery
On site anywhere in the world, or remotely, as a defined assignment or interim role.
Have a project or planning problem on your desk?
Tell me what you are working on. A short call is usually enough to see whether I can help.