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Head of Viral Vector and Cell Bank Analytics, Cell Therapy

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Job ID R0047961 Date posted Sep. 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, Viral Vector and Cell Bank Analytics, Cell Therapy, in our Cambridge office.

Takeda’s Cell Therapy Analytics team is seeking an experienced Director level candidate to head our viral vector and cell bank analytical team. The ideal candidate will be responsible for cell therapy viral vector and cell bank analytical strategy, overseeing a team executing analytical plan, 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 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 charateriztion.

  • 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

POSITION ACCOUNTABILITIES:

  • Provide strategic, technical and scientific leadership to Cell Therapy analytical development team

  • Accountable for Viral vector and cell bank analytical strategies across various cell therapy pipelines, making decision on testing strategy and communicate with different stake holders

  • Direct a team focusing on viral vector and cell bank (e.g. MCB for antigen presenting cells, MCB for viral production) assay development, qualification and Tech transfer to external CROs or internal partner functions for GMP and non-GMP testing

  • Provide input in supporting viral vector and cell bank process development and manufacturing

  • Strengthen molecular assay capability by recruiting, retaining and developing key talents; mentor junior scientists   

  • 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:

  • Degree in engineering or life sciences (such as Biotechnology, Immunology, Molecular Biology, Biochemistry, Bioinformatics)

  • Minimum PhD+10 years, MS+13 years and BS+15 years experiences in pharmaceutical development and manufacturing environment;

  • 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 and life cycle management on viral vector and cell bank

  • Understanding of viral vector and cell bank manufacturing process is a big plus

  • Strong knowledge and hand-on experiences on molecular based titer assays, cell based potency assays, impurity assessment, as well as CRO/CMO management

  • 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

Effective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles.  US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.

TRAVEL REQUIREMENTS:

May require approximately 15% travel.

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This job posting excludes CO applicants.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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