Executive Director, Head of ADC/Bio II, Project Lead

1 month ago

Bernards NJ United States Daiichi Sankyo, Inc. Full time

Join a Legacy of Innovation 110 Years and Counting

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary

The Job holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible for developing/proposing integrated CMC product strategy based on a cross functionally designed strategy, as well as developing activity plan, and budget for project. He/she (or subordinates) will lead cross-functional product decision and manage project team by working with other L-1 functions to get the appropriate talent. He/she (or subordinates) has responsibility to be an interface with R&D as the CMC working group leader of GPT. He/she will supervise the PJ Lead ADC/Bio#2 member and is the accountable for the ADC/Bio#2 and an integral member of the decision making in the Project lead.

Responsibilities

  • Develop/propose (or have subordinates) integrated CMC product level strategy (manufacturing site selection for internal vs. external manufacturing and CDMO selection, exit activity plan, etc.) based on a cross-functionally designed strategy, during (end-to-end) product life cycle.
  • Develop (or have subordinates develop) activity plan, and budget for project in alignment with Unit strategy, plan, budget and CDP. Lead (or have subordinates lead) cross-functional product decisions including approach for tech development, manufacturing network strategy, and change control strategy/planning as chair of PAC-MT, etc.
  • Manage (or have subordinates manage) project team by working with other L-1 functions to get the appropriate talent assigned to PJ team, and to delegate/monitor function specific work to each member. Be (or have subordinates be) an interface with R&D unit as the CMC working group leader of GPT and ensure alignment across the two Units. Ensure that all or a part of members participate in mutual peer evaluation operated by Tech. Strategy and Planning, Tech. Org. People Enablement (L-2) function. Participate in CMC/SC-related decision-making meeting bodies with strategic alliance partners (e.g., global pharmaceutical companies) as a working representative, upon request.


Education Qualifications (from an accredited college or university)

  • Bachelor's Degree Degree required in chemistry, biochemistry, pharmaceutics or related discipline within the pharmaceutical/biotechnology sciences required
  • PhD preferred

Experience Qualifications

  • 10+ years of professional experience with at least 2+ years in a direct or matrix management position of a CMC-related function in the pharmaceutical/biopharmaceutical industry (preferably in a global company).
  • 10+ years of expertise in project management, process, product, and/or analytical development activities and oncology project development.
  • Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA submission experience for ADC/Bio required.
  • Expertise in oncology strongly preferred

Travel

Ability to travel global and domestic up to 30%


Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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