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Associate Director, Advanced Analytics, Cell Therapy

Cambridge, Massachusetts

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Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

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Associate Director, Advanced Analytics, Cell Therapy

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Job ID R0022442 Date posted 08/31/2020 Location Cambridge, Massachusetts

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Job Description

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 an Associate Director, Advanced analytics, Cell Therapy, in our Cambridge office.

As an Associate Director working on the Cell Therapy Analytics team, you will be empowered to drive advanced characterization and critical quality attribute analysis related to Cell therapy products.  

POSITION OBJECTIVES:

  • Accountable for the leadership of the Cell Therapy analytical development team, including defining its vision, strategy, execution, hiring, training, staff assignment, coaching, mentoring and performance management.
  • Accountable for analytical development capabilities buildup and integrating analytical methods into early stage clinical manufacturing, product release testing, and product characterization.
  • Responsible for the successful transfer of early phase analytics from biotech and academic partners or internal programs.
  • Accountable for developing and executing Cell Therapy CMC strategies to enable and deliver IND and BLA filings.
  • Responsible for establishing operating budgets and managing expenses within those budgets

    Takeda’s Cell Therapy Analytics team is seeking an Associate Director to have overall responsibility for leading and managing advanced analytics for cell therapy pipelines, which includes but not limited to advanced analytical platform evaluation and implementation, deep characterization of cell therapy products and CQA correlative studies. The ideal candidate will also assume a key leadership role in the development of analytical strategies for cell therapy pipelines. 

POSITION ACCOUNTABILITIES:

  • Provide strategic, technical and scientific leadership to Cell Therapy analytical development team
  • Accountable for advanced analytical capabilities buildup and team management
  • Lead and manage analytical activities for extended characterization of cell therapy products
  • Oversee product CQA study plan, execution and data analysis
  • Review/approve technical reports, controlled clinical manufacturing sample analysis documents (e.g., analytical methods and associated protocols, SOPs, etc.) and incorporate regulatory documents.
  • 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 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.
  • Significant prior experience in driving characterization of cell and gene therapy products and correlative studies for product CQA discovery
  • Deep understanding in advanced analytical platforms and related data analysis, e.g. RNAseq, 20+ 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
  • Understanding of various cell and gene therapies, gene editing technologies with previous experience in CAR T or CAR NK products
  • Prior experience with IND, NDA or BLA desirable

TRAVEL REQUIREMENTS:

May require approximately 15% travel.

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0022442

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