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Head of Analytical Operation, 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.

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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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Head of Analytical Operation, Cell Therapy

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Job ID R0033315 Date posted 04/20/2021 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 Head, Analytical Operation, Cell Therapy, in our Cambridge office.

POSITION OBJECTIVES:

Takeda’s Cell Therapy Analytics team is seeking an senior team member to lead our Analytical Operation team. The ideal candidate will be responsible for cell therapy analytical operation, overseeing testing and data management, and supporting regulatory filing process related to cell therapy products. The candidate will also assume a key leadership role in the development of analytical strategies for cell therapy pipelines. 

POSITION ACCOUNTABILITIES:

  • As a senior leader within the Cell Therapy Analytics team, provide strategic, technical and scientific leadership to Cell Therapy Analytical Development team

  • Accountable for leading the analytical operations team to define and implement operational efficiency strategies for the across the organization

  • Build and manage a testing team, drive analytical testing support for process development, and product characterization.  

  • Oversee analytical data management, integration and archiving. Implement data visualization strategies. 

  • Review/approve study protocols and reports, manage internal and QA review 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 10 years of relevant industry experiences

  • Experience in operating globally in a highly matrixed organization

  • 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 development and team operation

  • Ability to work effectively within a team in a fast paced environment and strong organizational, planning and follow-up skills

  • Extensive knowledge of analytical development activities supporting process development, process and product characterization

  • Prior experience with IND, NDA or BLA desirable

  • Understanding of various cell and gene therapies, gene editing technologies with previous experience in CAR T or CAR NK products is strongly preferred

  • Prior experience in in vivo pharmacology and animal welfare regulations is a big plus

  • Prior experiences in Data analysis, visualization and management is strongly preferred

TRAVEL REQUIREMENTS:

May require approximately 15% travel.

#LI-KD1

This job posting excludes CO applicants.

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0033315
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