Represent GMSci and CMC in global product governance for at least two commercial products
Lead a cross functional CMC subteam defining and driving effective submission support and life cycle management activities for at least two products within Takeda’s commercial biologics portfolio
Provide strong leadership for LCM initiatives, submission plans, and investigations which are complex or span across multiple products.
Support the delivery of product and maintain continuous supply of commercial product
Define and implement plans / roadmaps for lifecycle initiatives for products
Execute CMC strategy and submission plans to support regulatory filings for product launch and to enable market expansion
Implement plans to achieve post-marketing and regulatory commitments
Support the enhancement of product and process knowledge and define and address process gaps through application of QbD best practices
Provide adequate SME support of major process and methods investigations.
WHAT TAKEDA CAN OFFER YOU
Excellent conditions & benefits including generous holidays
Genuine career progression and development
Opportunity to work with a world class leader in the pharmaceutical sector
At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company.
To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.