Director CMC Management (m/f/x)

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Date: 22-Jun-2022

Location: Pfaffenhofen an der Ilm, Germany, 85276

Company: Daiichi Sankyo Europe

 

Passion for Innovation. Compassion for Patients.

 


Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For more information: www.daiichi-sankyo.eu.

 

For our offices in in Pfaffenhofen an der Ilm / Munich we are seeking highly qualified candidates to fill the position

 

Director CMC Management (m/f/x)

 

The position:

The position Director CMC Management includes knowledge-based leadership, coordination and management for multiple projects and related internal and external CMC development teams to expedite successful product development and regulatory approvals. The qualified candidate will oversee CMC development strategies and operational plans across a portfolio of projects. He/she ensures that they are aligned with the strategic and operational objectives of the Global Pharmaceutical Technology function as well as those of the R&D, Commercial and Supply Chain functions. Furthermore the Director CMC Management represents CMC development teams on global and regional crossfunctional drug development project teams with both a strategic and operational focus and liaison with global and regional senior management. He/she is accountable for the coordination and management of global and regional development candidates in both early and late phase drug development and will deliver on the project goals according to agreed upon timelines.

 

Role and Responsibilities:

  • Strategic and operational leadership and coordination of global and regional CMC development teams (CMC sub-teams) for late phase drug development candidates
  • Regional driver for global and regional establishment of potential future new modalities platforms such as e.g. vaccines, gene therapeutic or other nucleotide-based drugs
  • Accountable for the establishment of integrated global and regional CMC operational plans and oversee their execution
  • Representation of  CMC development teams on global and regional crossfunctional drug development project teams
  • Ensure alignment of CMC operational plans with overall project plans; facilitate the timely execution of drug development project plans through proactive management of operational interfaces between the CMC development team and other functions
  • Provide project management and operational oversight of  vendor (CXO) services, managing contracts, timelines, budgets and deliverables, and coordinating the input of technical and functional experts as required; CXO services covered include drug substance manufacturing, drug product manufacturing and analytical testing services
  • Planning and supervision of project related budgets
  • Co-leads the regional and global stakeholder management and periodic reporting related to CMC Management
  • DSE representative in global Working Teams and initiatives to transform and optimize CMC Management, CMC Planning, and global PT function

 

Skills and additional Requirements:

  • Ph.D. in biochemistry, , pharmacy, (bio)chemical engineering or other discipline within biotech sciences with a minimum of 5 years pharmaceutical development or production experience, or a corresponding Master’s/Bachelor’s degree with a minimum of 7 years’ experience
  • At least 3 years of experience in CMC development project leadership (covering First-In-Man until Launch)
  • Experience in biologics or new modalities, drug substance and drug product development and/or production
  • Experience in CMC regulatory strategy development and regulatory filings
  • Proven ability to collaborate with functional representatives to anticipate and identify project risks and develop action and resolution plans
  • Proven ability to work effectively with crossfunctional stakeholders in a complex/evolving global environment
  • Demonstrated matrix management skills and clear ability to influence and effectively align, motivate and empower the team to progress project goals in a crossfunctional team environment
  • Must be flexible in response to changing priorities due to various time zones (EU, US & Japan)
  • Strong working knowledge of Microsoft Office

 

The following is preferred:

  • Advanced experience in late-stage development  of complex biopharmaceuticals such as antibody-drug conjugates, bispecifics, etc.

 

 

What we offer


Working at Daiichi Sankyo

At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.