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Define.

Enable.

Execute.

Helping biotech companies navigate transitions — from CMC strategy to operational execution. Exactly When You Need It

You are transitioning from R&D to a clinical-stage company, but your CMC strategy isn't ready for manufacturing:

  • CDMO Selection

  • CMC Strategy Alignment

  • Business Process Mapping and Implementation

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Manufacturing Strategy

Your team is facing critical timelines or sudden transitions, and they need clear, steady leadership right now.

  • Leadership of Technical Teams

  • CMC Support of Board Functions

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Leadership Excellence

Your technical data is solid, but a disconnect between Clinical, Commercial, and CMC is putting your funding at risk.

  • CMC Management

  • External Manufacturing Lead

  • CMC Project Lead

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CMC Management

Let´s Talk!
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About

I bridge the gap between complex bioprocessing and corporate strategy.

Moving a biologic from the lab to a clinical manufacturing campaign is never a straight line. Yet, CMC topics are frequently overlooked in the early stages, right up until it becomes a critical liability that risks your funding or timelines.

I’ve spent over 15 years in the biopharmaceutical industry specializing in MS&T and Process Science. Over a career of leading large teams, managing complex CMC programs through to BLA submissions, and designing GMP-compliant facilities, I learned a vital lesson: your technical data is only as good as the strategy executing it.

That’s why I operate as a Fractional Leader. I step directly into your organization to handle the operational heavy lifting, giving you tier-1 executive expertise exactly when you need it, without the overhead, equity commitments, or recruitment lag of a full-time hire.

Fractional Expertise. Zero Executive Overhead.

"Stop consulting from a distance and start executing. I provide hands-on, fractional technical leadership tailored precisely to your biopharma lifecycle, from discovery to scaling manufacturing. No corporate hand-holding, no drawn-out ramp-up—just practical, evidence-based strategies that protect your timelines and satisfy your board."

During a Workshop Andreas is discussing with Marine a the CMC strategy and how this aligns with investor communication and financing strategy
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  • "...Andreas is an excellent communicator with a talent for simplifying complex topics and translating them into clear needs and actions..."

    —Roman Necina

  • "Andi is a high-integrity colleague who is pragmatic, collaborative, and deeply focused on shared company objectives. I always valued his technical insights and would recommend him to any organization."

    —Mark McKechnie

  • "...we built up a great collaboration between our teams and succeeded in bringing GMP material for an innovative therapy to clinical trials."

    —Janet Hoogstraate

  • "...enabled us to implement major improvements to the company’s manufacturing processes and analytical toolbox in a remarkably short timeframe."

    -Kerstin Rumpelmayr

  • "I worked with Andi for more than 7 years at Hookipa and can strongly recommend him for a leadership position in process development and/or manufacturing of biological products."

    -Anders Lilja