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