The Senior Director, Drug Product Development - Vaccine Operations will be responsible for:
- Establishing Takeda as a leader in vaccine formulation development sciences and the use of adjuvants in vaccines through the application of next generation technologies for characterizing and optimizing the formulation of Takeda s vaccine products
- Creating and implementing formulation strategies and drug product development activities to support licensure of Takeda s vaccine products.
- Lead the design and execution of pre-formulation, formulation development and optimization activities, as well as development of drug product manufacturing processes for the Takeda Vaccine portfolio
- Establishing leadership across industry working groups and with regulatory agencies to advance Takeda s vaccine development goals.
- Leadership in the development and application of next generation technologies and adjuvants for the formulation of Takeda s vaccine products.
- Characterize final drug product to determine the interaction of adjuvants and antigens and their impact on product quality, potency, safety and efficacy
- Establishing leadership across industry working groups to build scientific consensus behind novel approaches to vaccine formulation that advance Takeda s vaccine development goals.
- Interfacing with regulatory agencies on product formulation strategies and drug product manufacturing processes and apply broad knowledge on quality and regulatory requirements to advance development and licensure of Takeda s vaccines.
- Overseeing planning and execution of formulation development as well as drug product process development and tech transfer for clinical-stage vaccines in line with stage-appropriate expectations
- Author and review CMC documentation, including technical and quality sections, for submission to regulatory agencies; e.g., IND, CTD.
- Supporting improvements to formulation methods for commercial vaccines and execution of formulation improvements for post-licensure changes.
- Coordinate with contract research organizations to accomplish the goals of Formulation Development group.
- Partnering with CMC to develop strategies and formulation techniques in support of product enhancements.
- Utilizing external networks to identify and evaluate partners for the conduct of formulation methods.
- Will work closely with the COO leadership team on the assessment of new product candidates from internal research and external partnerships.
- Will be responsible for building and managing Takeda s Vaccine Drug Product Development organization, including talent recruitment and management.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- MS or PhD and a minimum of 15 years experience in biologics formulation development and drug product manufacturing science; or BS with a minimum of 20 years experience in biologics formulation development and drug product manufacturing science.
- Should have the potential to lead transformational changes in formulation development strategies within the vaccine industry
- Should be a self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of structured product development
- Demonstrated technical knowledge of formulation technologies, quality and regulatory requirements (ICH, FDA guidelines). Direct experience with regulatory authorities is preferred.
- Established external network of service providers, technical experts, suppliers, and technology providers.
- Proven experience in a matrix environment able to lead and manage a team, serves as a partner, and influences others.
- Demonstrated ability to work with efficiency across multiple project teams and business functions.
Empowering Our People to Shine
Learn more at takedajobs.com.