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.
- 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
- 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
- 20-30% travel; both domestic and international
Learn more at takedajobs.com.
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