Head of Analytical Operation, Cell Therapy
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Head of Analytical Operation, Cell TherapyApply Now
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.
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.
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
May require approximately 15% travel.
This job posting excludes CO applicants.
Time TypeFull time
Job ID R0033315