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Executive Director, Head of ADC/Bio II, Project Lead
2 months ago
We are seeking a highly experienced and skilled CMC Project Lead to join our team at Daiichi Sankyo, Inc. as the Head of ADC/Bio II. This role will be responsible for leading cross-functional product decisions, developing integrated CMC product strategies, and managing project teams.
Key Responsibilities- Develop and propose integrated CMC product strategies, including manufacturing site selection and CDMO selection, to ensure alignment with unit strategy and plan.
- Lead cross-functional product decisions, including approach for tech development, manufacturing network strategy, and change control strategy/planning.
- Manage project teams by working with other L-1 functions to get the appropriate talent assigned and delegate/monitor function-specific work to each member.
- Bachelor's Degree in chemistry, biochemistry, pharmaceutics, or related discipline within the pharmaceutical/biotechnology sciences.
- 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.
- Extensive knowledge of global CMC regulatory requirements and preferably NDA or BLA submission experience for ADC/Bio.
Ability to travel globally and domestically 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.
