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Senior Director, Vaccine Process Development

応募 後で応募 求人ID R0013227 掲載日 10/10/2019 Location:Cambridge, Massachusetts

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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 (Master’s Degree or PhD) in a scientific or technical discipline is strongly preferred, although a Bachelor’s 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.

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Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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