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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.
Locations
Zurich, Switzerland
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
