Head of Product Characterization & Advanced Analytics, Cell Therapy
Posted on Apr 6, 2021 by Takeda Pharmaceuticals
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as Head Product Characterization and Advanced Analytics, Cell Therapy, in our Cambridge office.
As the Head Product Characterization and Advanced Analytics within our Cell Therapy Analytics team, you will be empowered to drive product characterization and critical quality attribute analysis related to our Cell therapy pipeline.
Takeda's Cell Therapy Analytics team is seeking a candidate with a strong immunology background to lead the Product Characterization and Advanced Analytics group. The ideal candidate will have an overall responsibility for cell therapy product characterization, as well as advanced analytical platform evaluation and development for product CQA analysis. The ideal candidate will lead a team working closely with Process development, Engineering and automation, Translation and Clinical team to advance the understanding of T cell and NK cell based novel therapy modalities. The position will also assume a key leadership role in the development of analytical strategies for cell therapy pipelines.
Provide strategic, technical and scientific leadership to Cell Therapy analytical development team
Accountable for analytical strategies and activities related to cell therapy product and process characterization, which includes but not limited to, the development and optimization of in-process testing, starting material and product characterization
Lead and manage analytical activities for advance analytical platform buildup and extended characterization of cell therapy products
Drive product CQA correlative strategy, oversee study plan, execution and data analysis
Review/approve technical reports, controlled clinical manufacturing sample analysis documents (eg, analytical methods and associated protocols, SOPs, etc.) and incorporate regulatory documents.
Manage and mentor scientists of varying levels to build a highly functional AD team
Accountable for developing and executing Cell Therapy CMC strategies to enable and deliver IND and BLA filings.
Collaborate closely with other key line functions and communicates complex data/decisions within department and cross functionally
Responsible for integrating scientific/technical efforts around cross-functional issues
EDUCATION, EXPERIENCE AND SKILLS:
Advanced degree (PhD highly desirable) in relevant scientific discipline (such as Biotechnology, Immunology, Molecular Biology, Biochemistry, Bioinformatics) with minimum 7-10 years of relevant industry experiences
Excellence and successful track record in leadership, people management and managing interfaces with other functions and integrated teams
Proven track record and demonstrated deep understanding of pharmaceutical drug development, program and project development
Strong scientific background on T cell and NK cell immunology is a must
Significant prior experience in driving characterization of cell and gene therapy products for process assessment and correlative studies for product CQA discovery
Significant prior experiences in advanced analytical platforms and related data analysis, eg RNAseq, multi-color flow cytometry and/or single cell analytical assays
Knowledge of clinical manufacturing sample management and analysis plan
Prior experiences in cell products in vivo characterization is a big plus
Prior experience with IND, NDA or BLA desirable
TRAVEL REQUIREMENTS: May require approximately 15% travel