Director CMC Management (m/f/x)

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Date: 17-Aug-2019

Location: Pfaffenhofen an der Ilm, Germany

Company: Daiichi Sankyo Europe

Affiliate: Daiichi Sankyo Europe GmbH

 

Passion for Innovation. Compassion for Patients.™

Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology”. Our European headquarters are in Munich, Germany and we have affiliates in 13 European countries. For more information: www.daiichi-sankyo.eu.

For our development site in Pfaffenhofen/Ilm we are seeking highly qualified candidates to fill the position:

 

Director CMC Management (m/f/x)

 

The qualified candidate will provide knowledge-based leadership, coordination and management of global and regional CMC development teams (CMC sub-teams) across the company’s organizational matrix for multiple early and late phase drug development programs. The candidate will represent CMC development teams on global and regional cross-functional drug development project teams with both a strategic and operational focus and will liaison with global and regional senior management. One of the key-responsibilities will be project management and operational oversight of vendors (CXO) involved in activities that cover the range of CMC functions.

CMC development teams are 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. This position requires a solid technical understanding of drug substance process development and manufacturing, drug product formulation development and manufacturing, analytical methods development and validation, technology transfer and scale-up, process characterization and validation, clinical and commercial supply operations, and CMC regulatory and GMP compliance requirements.

The actual scope of programs may cover both, NCE and NBE development programs. A preferred candidate however, has a strong biochemistry/bioconjugation background and experience in the development of complex biologics modalities such as Antibody Drug Conjugates (ADCs).

 

Key responsibilites:

  • Operational coordination and management of global and regional CMC development teams (CMC sub-teams) for multiple early and late phase drug development candidates
  • Facilitate the establishment of integrated global and regional CMC operational plans and oversee their execution
  • Represent CMC development teams on global and regional cross-functional drug development project teams with a predominantly operational focus
  • 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 routine 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

 

Requirements:

The following is required:

  • Ph.D. in biochemistry, (bio) chemical engineering, chemistry, or other discipline within biotechnology sciences with a minimum of 5 years industrial experience, or a corresponding Master’s/Bachelor’s degree with a minimum of 7 years industrial experience
  • At least 5 years of experience in the pharmaceutical/biotechnology industry working in a biologics drug development environment
  • Experience in biologics processing, product or analytical development activities and knowledge of CMC regulatory requirements
  • A working knowledge of the roles, responsibilities, and operational requirements of all functions represented on CMC development teams
  • Demonstrated matrix management skills and clear ability to influence and effectively align, motivate and empower the team to progress project goals in a cross-functional team environment
  • Proven ability to work effectively with cross-functional stakeholders in a complex/evolving global environment
  • Proven ability to collaborate with functional representatives to anticipate and identify project risks and develop action and resolution plans
  • Experience in regulatory strategy development, regulatory filings, and meetings with regulatory agencies, as appropriate
  • Excellent oral and written English skills

 

The following is preferred:

  • Experience in the development of Antibody Drug Conjugates (ADCs)
  • Experience working within a global matrix organization

 

What we offer:

 

We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.