Head of Analytical Development for Cell Therapy
4 weeks ago
Takeda is seeking a highly skilled and experienced Head of Analytical Development for its Cell Therapy department. As a key member of the team, you will be responsible for leading the development and implementation of analytical strategies and methods to support the development of cell and gene therapies.
The ideal candidate will have a strong background in analytical development, with experience in the development and implementation of molecular, physical-chemical, and bioassay analytics. You will be accountable for ensuring optimal interfaces and matrixed ways-of-working across Research Functions, and will have hands-on experience in assay automation and digitalization.
You will be responsible for providing strategic, technical, and scientific leadership towards the development and implementation of innovative, robust, cost-efficient analytical capabilities across Takeda cell therapy platforms and programs. This includes establishing testing strategies (using manual and automated methods) to support process development, process characterization, and stability studies in support of establishing process understanding and control strategies.
The Head of Analytical Development will work closely with other Development leaders (Process and Product Development; Automation; Data & Digital; Strategy) to optimize the development of our drugs, including definition of optimal Control Strategy, Release Assays, and Characterization/Functional Assays. You will also be responsible for establishing strong relationships and collaborating closely across multiple functions as well as externally with partners (e.g., CROs).
Key Responsibilities
- Develop and implement analytical strategies and methods to support the development of cell and gene therapies
- Lead the development and implementation of molecular, physical-chemical, and bioassay analytics
- Ensure optimal interfaces and matrixed ways-of-working across Research Functions
- Provide strategic, technical, and scientific leadership towards the development and implementation of innovative, robust, cost-efficient analytical capabilities
- Work closely with other Development leaders to optimize the development of our drugs
- Establish strong relationships and collaborate closely across multiple functions as well as externally with partners
Requirements
- PhD in Biotechnology, Cell Biology, Biochemistry, Chemical Engineering, or a related discipline with 7+ years relevant industry experience
- Excellent communication/presentation skills and scientific/technical writing skills
- Demonstrated ability to work in matrixed teams and resource-constrained environments
- Excellent interpersonal skills and demonstrated ability to influence across Functional and Company borders
- Proven track record as Cell Therapy development leader, with breadth of exposure across the spectrum of CMC functional responsibilities
- Passionate about mentorship, culture, and nurturing the development of scientific talent, with direct experience leading high-performing teams
- Good understanding of ICH, FDA and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of pharmaceutical development
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