Manufacturing Science and Technology Expert - Drug Product

Manufacturing Science and Technology Expert - Drug Product

Lonza

Visp, Switzerland

We are looking for a Manufacturing Science and Technology Expert - Drug Product - 80% -100%. This role is important for ensuring successful technology transfers, maintaining GMP compliance, and driving continuous improvement. If you're a proactive problem-solver with a strong background in manufacturing science and technology, we want to hear from you.

Key responsibilities:

• Responsible for implementing the manufacturing process in the plant, as received from DP process development or customer.
• Securing success during technology transfer by applying formal processes and tools to handle the transfer of information, process related risks and change control.
• Participate in GMP risk analysis for the manufacturing processes.
• Communication of manufacturing updates to the customer.
• Leading and/or participating in cross-functional teams as a MSAT guide tasked with technology transfers (process implementation and transfer) and timely process implementation at manufacturing scale. This includes the whole lifecycle of assigned projects from planning over coordination, implementation, control and project completion aligned with project management goals.
• Leading/participate in change controls and deviation investigations.
• Prepare and perform Qualification and Validation ‎activities in compliance with cGMP regulations and ‎specification requirements. ‎‎
• Contributing to the development and implementation of standardized MSAT procedures and processes.
• Responsible for continuous improvement of process performance and product quality.
• Proactively anticipates, evaluates, and resolves scientifical and technical challenges within area of expertise.
• Acting as a mentor for scientific and production staff in different fields of expertise.
• Acts a link between Drug Product Services (DPS Basel), mainly formulation, process development and manufacturing, QC and Visp.
• Looks after process monitoring and process control strategy as well as sophisticated data analysis.

Key requirements:

• Degree in Pharmaceutical Technology, Biotechnology, Chemistry, Process Engineering or equivalent scientific degree.
• More than 3 years of proven track record in the area of sterile manufacturing on the shopfloor and/or MSAT, QA/QC.
• Proficiency in English.
• Proven process understanding in sterile manufacturing (Pharma, Regulatory aspects, freeze-drying).
• Very good interpersonal skills with all kinds of interfaces within customers and the project organization.
• Strong team orientation and collaboration across groups within a matrix organization.
• Structured, focused and well-organized working demeanor.
• Open-minded for new insights and suggestions.
• Agile, highly motivated and dynamic drive.
• Driven to resolve issues.