Associate Director - Clinical Assay Development (Cell Based / Functional Assays) at Takeda Vaccines, Inc.

Posted in General Business 29 days ago.

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Type: Full-Time
Location: Cambridge, Massachusetts





Job Description:

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Job Description

OBJECTIVES:

The Clinical Assay Development Associate Director within the Discovery Department will be responsible for:


  • Contribute to establishing Takeda as a leader in vaccine clinical assay sciences through the integration of transformational technologies and contemporary biopharmaceutical strategies.

  • Development and Validation of analytical techniques for clinical and pre-clinical sample testing to support licensure of Takeda’s vaccine products.

  • Execution of Assay Qualifications and Validations under appropriate regulatory guidelines – CBER, EMA, ICH

  • Managing external relationships with CROs and academic institutions to facilitate Takeda Vaccine Development.

  • Oversight of internal early phase sample testing

ACCOUNTABILITIES:


  • Technical leadership in Cell Based Functional Assays, with the ability to design and develop assays from inception through validation.  

  • Experienced in the qualification and validation of assays in a regulated environment in accordance with CBER, EMA, regulatory guidelines and best practices.

  • Internal partnering with Analytical Development, CMC, and Clinical groups to develop strategies and techniques in support of vaccine clinical assay development.

  • Managing external relationships with CROs / Vendors with respect to the outsourcing of clinical assays

  • Utilizing external networks to identify and evaluate partners for the conduct of clinical assays. 

  • Regulatory/technical guidance to staff conducting in house early phase sample testing  

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:


  • PhD and a minimum of 10 years experience or MS and a minimum of 15 years experience in vaccine or biologics clinical assay development.

  • Extensive Functional Assay experience.  Immunoassay and Molecular assay experience a strong plus.

  • The candidate should be a self-starter and team player, with the ability to effectively communicate updates, and issues across departments to a varied audience

  • Ability to take the lead and interact effectively with outside vendors and asses CROs technical and operational capabilities

  • Proven experience in a matrix environment.

  •  Demonstrated ability to work efficiently across multiple project teams and business functions.

  • Strong communication Skills

  • Tactical problem solver

TRAVEL REQUIREMENTS:

  •  20%

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Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time