Posted to MedZilla on 3/21/2019


Takeda Pharmaceuticals

US-MA, Senior Director, Drug Product Development - Vaccine Operations R0007148-MZ


 
 

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Job Description

OBJECTIVES:

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.

ACCOUNTABILITIES:

  • 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.

TRAVEL REQUIREMENTS:

  • 20-25%

Empowering Our People to Shine

Learn more at takedajobs.com.

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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