Associate Director Vaccines MS&T Drug Products

Vor 5 Tagen

Stäfa, Schweiz Takeda Vollzeit

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

OBJECTIVE:

  • Provide leadership and oversight of cGMP activities for Drug Product (DP) manufacturing
  • Lead and oversee development and technology transfer activities for DP
  • Implement manufacturing solutions to enhance quality, productivity, and robustness of manufacturing processes
  • Collaborate with cross-functional teams to plan and introduce process improvements, scale-ups, transfers, and lifecycle management projects
  • Assist to guide and further develop a team of (senior) process engineers supporting both projects and commercial manufacturing in external and internal sites

ACCOUNTABILITIES:

  • Provide scientific and technical leadership and coaching to internal and external manufacturing teams
  • Develop and implement robust strategies for manufacturing process improvements, process scale-up, technology transfers and other life cycle management initiatives like introduction of new manufacturing technologies while ensuring compliance with GMP and global health regulations
  • Represent Manufacturing Science & Technology in cross-functional project teams and external manufacturing teams, define and coordinate communication of program status as well as issue escalations and mitigations
  • Apply risk management principles and methodologies throughout lifecycle management
  • Author and review of process manufacturing documentation and regulatory submissions
  • Manage data and analysis of operational parameters, including Continuous Process Verification (CPV) and Annual Product Review (APR)

CORE ELEMENTS RELATED TO THIS ROLE:

  • Leadership in cGMP activities, deviation and change management, and technology transfer for DP manufacturing
  • Implementation of manufacturing solutions to enhance quality, cost, and robustness
  • Collaboration with cross-functional teams for process improvements, scale-ups, transfers, and lifecycle management projects
  • Building partnerships for awareness of new technologies

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise:

  • Thorough understanding of formulation processes, aseptic filling, isolator technology, lyophilization, visual inspection, and packaging
  • Experience in single-use materials application to sterile manufacturing
  • Good understanding of analytical assays / process analyzer technologies associated with manufacturing controls in biopharmaceutical manufacturing
  • Experience working with vaccines and especially live viruses vaccines desired
  • Basic knowledge of up-stream and down-stream processing unit operations in, including single-use technologies desired

Leadership:

  • Proven ability to lead cross-functional teams and influence others
  • Experience in mentoring and developing technical staff
  • Ability to balance entrepreneurial needs with structured product development

Decision-making and Autonomy:

  • Capacity and authority to make organizational decisions
  • Autonomy in decision-making with significant impact on manufacturing processes
  • Strong problem-solving skills for technical challenges and deviations

Interaction:

  • Extensive engagement with internal and external stakeholders
  • Collaboration with global Takeda organizations and cross-functional teams
  • Effective communication at all levels of the organization

Innovation:

  • High level of scientific knowledge and innovation in manufacturing processes
  • Knowledge sharing and risk-taking to implement new technologies

Complexity:

  • Management of complex DP manufacturing processes
  • Navigating internal and external business environments and cultural considerations

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Education: BS with a minimum of 10 years, MS with a minimum of 7 years or PhD with a minimum of 5 years of experience in cGMP manufacture for DP processes. Experience with live viruses is a plus
  • Leadership Experience: Minimum of 3 years of direct or matrixed leadership experience
  • Technical Knowledge: Expertise in single-use technologies, formulation processes, aseptic filling, packaging and related technologies
  • Skills: Self-starter, team player, excellent organizational skills, and effective communication. Proven ability to lead and manage cross-functional teams
  • Language: Proficiency in English is required. German and other languages knowledge are a plus

ADDITIONAL INFORMATION:

  • Travel: Willingness to travel (20%-30% domestic & internationally)
  • Ability to gown in accordance with site-specific procedures for entering clean rooms.
LocationsZurich, SwitzerlandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time #J-18808-Ljbffr

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