Posted to MedZilla on 8/18/2019


Takeda Pharmaceuticals

US-MA, Associate Director, Vaccines Analytical Program Lead R0009851-MZ


 
 

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Job Description

OBJECTIVES:

The Associate Director, Vaccines Analytical Program lead position within Vaccine Analytical Development will be responsible for:

  • Establishing Takeda as a leader in vaccine analytical science through the application of processes, procedures and technologies in the development of best in class vaccine analytical strategies.
  • Provide expertise for the validation and technical transfer of potency assays to external laboratories and national labs in support of commercial testing of Takeda s vaccine products.
  • Establish leadership across industry working groups and with regulatory agencies to advance Takeda s vaccine analytical goals.
  • Ensure full alignment with AD activities and TDT contract deliverables
  • Oversee and manage external and internal cross-functional activities required to deliver program goals
  • Deep knowledge of virology and virus systems.
  • Represent AD on Technical Development and Global Program teams
  • Act as a cross-functional AD leader in the organization promoting scientific and operational excellence

ACCOUNTABILITIES:

  • Identification of innovative or cutting edge technologies and approaches to assay development to AD team.
  • Identifying potential improvements for existing assays and develop remediation plans/timelines.
  • Overseeing the planning and execution of assay trending/tracking strategies for assay monitoring in alignment with Program timelines.
  • Track appropriate support for a robust critical reagent sourcing/supply strategy.
  • Communicating technical information to Senior Management and external partners.
  • Writing and reviewing technical documents and regulatory submissions.
  • Interfacing with regulatory agencies and national laboratories on potency testing strategies to advance licensure of Takeda s vaccines.
  • Supporting development and commercial operations groups in the preparation of relevant regulatory filings.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • PhD and a minimum of 8 years experience or MS and a minimum of 10 years experience in vaccine or biologics GMP assay development or testing.
  • The candidate should have the potential to participate in transformational changes in potency testing strategies within the vaccine industry.
  • The candidate should be a self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a structured GMP testing environment.
  • Demonstrated technical expertise in an analytical discipline related to vaccine or biologic assay development.
  • Well developed knowledge of cGMP practices as applicable to formulation, analytical development, technology transfer, and manufacturing.
  • Established external network of service providers, technical experts, suppliers, and technology providers.
  • Proven experience in a matrix environment is preferred.
  • Demonstrated ability to work efficiently across multiple project teams and business functions.

PHYSICAL DEMANDS:

  • Lifting and moving supplies and equipment (up to 50 pounds).

TRAVEL REQUIREMENTS:

  • Willingness to travel to various meetings or client sites, including overnight trips. Including international travel may be required.
  • Up to 25% travel

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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