3 days old

Senior Director, Vaccine Process Development

Takeda Vaccines, Inc.
Cambridge, MA 02139
  • Job Code
    R0013227

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that I agree with Takedas Privacy Notice, Privacy Policy and Terms of Use.

Job Description

OBJECTIVES:

As a member of the Vaccine Operations (VO) Leadership team, this role is for a proactive, data-driven and strategic leader who serves as a single point of contact for all global vaccine process development activities.

  • Set strategy and establish industry-leading CMC capabilities for vaccine development. Establish strong connections to multiple geographically diverse process development teams as well as working with third-party contractors.
  • Drive the teams performance to develop robust processes across multiple programs and all phases of pre-clinical and clinical development up to licence submission.
  • Actively seek out cutting edge technologies in manufacturing of vaccines and develop collaborative internal and external networks.
  • Drive the global strategy for continuous and phase-appropriate process manufacturing optimization towards standardized platforms as appropriate.
  • Establish and foster a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity inclusion and trust.
  • Support foster a culture of a project-centric operating model.
  • Work effectively across the multiple CMC disciplines as well as with project leaders, discovery units, clinical teams and commercial manufacturing.
  • Together with the Head of Vaccine Operations CMC/R&D, lead and direct the VO strategy and the interface between portfolio management, project management and operations.
  • Drive the process development teams execution and proactively contribute to strategy by translating the strategy into operation activities.
  • Drive innovation with the objective to accelerate and de-risk process development, reduce cycle times and cost, as well as support tech transfer to manufacturing sites.
  • Provide portfolio and performance analysis dashboards to the VO Leadership Team to guide and support strategy through informed and data-driven decision making and effective communication with the team and towards the customers.

ACCOUNTABILITIES and RESPONSIBILITIES:

  • Accountable for all process development, clinical manufacturing, including mentoring and building our capabilities and operations personnel.
  • Oversee all process development activities across multiple programs with the aim of creating increased value through clarity of thought and attention to detail.
  • Accountable for building and effectively managing highly skilled teams of scientists, managers and process engineers in our global VO organization.
  • Accountable for establishing, continuously improving resource allocation plans and actuals, scientific information and knowledge.
  • Represent the VO function internally and externally on consortiums and industry organizations.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Background, Education and Experience:

  • Minimum of 12+ years of experience working in a cross functional biologics development group.
  • An advanced degree (Masters Degree or PhD) in a scientific or technical discipline is strongly preferred, although a Bachelors degree with significant and appropriate experience would be considered.
  • Track record of successful leadership, management and development of large multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make difficult decisions.

Technical Skills/Competencies:

  • Requires strong background in a technical / scientific discipline. Must have the maturity to utilize scientific and technical knowledge to provide unique solutions for the benefit of the development program.
  • Must demonstrate knowledge of multiple disciplines in biologics development, e.g., bioprocess engineering, analytics, formulation, validation, quality assurance and/or regulatory affairs.
  • Requires extensive knowledge of current Good Manufacturing Practices and Regulatory requirements related to Vaccine development and manufacturing.
  • Must be capable of clear and concise written communication skills with experience in authoring and reviewing regulatory documents for submission to global Health Authorities

Management Skills/Competencies

  • Ability to build strong partnerships and drive role clarity within the VO and Vaccine Business Unit organizations.
  • Be capable of broad decision-making responsibilities to make highly complex decisions while seeking diverse input from multiple constituents and stakeholders. Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution.
  • Must have a demonstrated ability to work across functions, regions and cultures
  • Be an enterprise leader with the ability to inspire, motivate and drive results
  • Should possess proven skills as an effective team player who can engender credibility and confidence within and outside the organization.
  • Requires ability to develop and use knowledge and interpersonal skills to influence and guide internal and external stakeholders towards the accomplishment of program and cross-divisional goals.
  • Requires ability to identify/solve technical, budgetary, and schedule risks to the program and propose appropriate risk response strategies.
  • Must be an excellent communicator that can distill complex concepts with clarity of thought in a concise and factual manner.
  • Embraces and demonstrates a diversity and inclusion mindset as role models these behaviors for the organization.
  • Ability to work in a global ecosystem (internal and external) with a high degree of complexity

TRAVEL REQUIREMENTS:

  • 20-30% travel; both domestic and international

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

#LI-KB1

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2019-10-10 Expires: 2019-11-08
Sponsored by:
Farm Credit Services of America Logo
Sponsored by:
Bank of America Logo

Featured Jobs[ View All ]

Featured Employers

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Senior Director, Vaccine Process Development

Takeda Vaccines, Inc.
Cambridge, MA 02139

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast