Head of Cmc

vor 1 Woche

Basel, Basel-Stadt, Schweiz Sobi Vollzeit
The Role

As Head of CMC, you will ensure that late development and lifecycle plan are translated in sustainable reality. For this, you can rely on a team of CMC project lead and CMC dossier managers. They manage end to end complex technical CMC projects, including budget and reporting, CMC regulatory strategy and scientific writing.

You will work closely with research and development, manufacturing and analytical science and technology, external manufacturing and sourcing, quality, finance, and clinical operations to make projects happen on time and on budget.

Your personality


The role is cross functional by essence, therefore you are used to work in a matrixial environment with numerous stakeholders and reporting line.

Seasoned people manager you can give strategic direction to your team and rely on your experience leading development teams facing complex scientific and technical challenges.

Excellent communicator you use to convey complex and detailed information to diverse audience, including executive management. You can deal with volatility, uncertainty, and ambiguity and work under pressure.

Content of the role:

  • CMC Program Management
  • Lead a team of CMC project leads, responsible of complex CMC project management with transversal responsibility (technical, budget, sourcing, regulatory strategy, launch) with the ultimate goal to be on time and on budget. Provide scientific strategy. Proactively find for option to accelerate projects.
  • Lead a team of CMC dossier managers supporting CMC regulatory strategy and writing the relevant CMC sections for both development projects and lifecycle activities related to commercial products.
  • Structure the CMC project management with tool and process to improve project efficiency, transparency and create the "Sobi way" to manage projects. Implement a gate process and run gate meeting to review the project status and risks and grant stakeholder approval to continue to the next step.
  • Be responsible of the CMC budget setup and work closely with the controllers to ensure we remain in budget.
  • CMC Strategy
  • Maintain a technology and competence master plan to ensure company readiness to include the new technologies and skills required to support the growth and acquisition strategy.
  • Lead a knowledge management program to keep the Sobi technological, process and analytical knowledge internally and ensure this knowledge is readily available for Sobi employees.
  • Support any technical due diligence as required.
  • PhD degree in science or other relevant degree (Engineering, Chemistry or alike)
  • 20+ years of experience in the pharmaceutical industry with proven track record of late phase development project.
  • Extensive knowledge in biopharmaceutical processes, preferably in biological drug substance processes.
  • International experience: experience of leaving abroad is a plus and management of international, virtual teams is required
  • People management experience: manager of managers, management of scientific/technical experts, multicultural teams
  • Project management: experience of leading complex technical lifecycle projects with internal and external stakeholders, deep understanding of project risk management and CMC regulatory strategy
  • Strategy: experience of settingup technical strategies in the pharmaceutical industry, for both drug substance and drug product
  • Experience of technical due diligence in the scope of sourcing projects and acquisition

Why Join Us?


We are a global company with around 1,500 employees in more than 30 countries, and are committed to the societies where we operate.

With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we're ready to take on the world's diseases, ailments and adversity.

Our people believe they have the power to make a positive impact in others' lives because that's exactly what we do here.

If you're seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture
At Sobi, we refuse to accept the status quo.

This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength.

By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them.


This has been our approach since day one, but we know we can't change the world of rare diseases on our own.

Accomplishing this requires strong partnerships with patients, partne

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