Associate Director - Clinical Assay Development (Cell Based / Functional Assays)
at Takeda Vaccines, Inc.
Posted in General Business 29 days ago.
This job brought to you by eQuest
Location: Cambridge, Massachusetts
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
- 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
Empowering Our People to Shine
Learn more at takedajobs.com.
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