Head of Cmc Program Management

vor 1 Woche

Basel, Basel-Stadt, Schweiz Sobi Vollzeit

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

Head of CMC Program Management:

Role & Function

As Head of CMC program management, 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.


Key Responsibilities

  • 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 and ensure the appropriate internal organization and external partnership are in place to execute the project on time and on budget.
  • 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. In collaboration with RA, ensure the program fits with the regulatory strategy and all support document, including module 2 and 3 are ready on time for submission
  • 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. Maintain an endtoend overview of the project status and budget and communicate effectively to the appropriate stakeholders.
  • Be responsible of the CMC budget setup and work closely with the controllers to ensure we remain in budget.
  • 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.
  • Provide strategic direction to the technical development (biological DS and DP process, packaging and analytical methods) in close collaboration with technical project leads.
  • In collaboration with procurement and project teams, ensure the contracts with the C(D)MO are in place and sourcing activities are completed on time
    Qualifications
  • 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
    Personal attributes

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.

In addition, you must demonstrate behaviors in line with Sobi's core values:
Care, Ambition, Urgency, Ownership and Partnership.

Location
The position will be based in Basel, Switzerland.

Reporting to
VP, Head of CMC, Sciences and Technology

**Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, co

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