Process Operations Specialist (Upstream Operations)

As a member of the growing manufacturing team, you will be responsible for supporting various activities related to the implementation and GMP manufacturing of early-phase clinical therapies.

Tasks & Responsibilities:

• Set up, practical execution and troubleshooting of upstream and support unit operations in continuous manufacturing and fed-batch processes under Good Manufacturing Practices (GMP).
• Involvement in continuous improvement efforts and support for the implementation of new technologies, including non-GMP engineering runs or testing activities.
• Creation and updates of SOPs and (electronic) master batch records. Technical review of various documentation related to process transfer and GMP manufacturing.
• Material management using ERP systems (SAP).
• Participation in sampling activities (including occasional weekend work) or on-call duties, as required by the process scheduling. Typical manufacturing activities do not include shift work.
• Knowledge of and compliance to GMP principles and EHS standards in the area of responsibility.

Requirements:

• A bachelor’s or master’s degree in life sciences or a related field.
• A minimum of 0-2 years of work experience in the pharmaceutical or biotech industry.
• Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
• Ability to perform under pressure in a complex GMP environment and assume responsibility. Flexible attitude when working with internal or external stakeholders to achieve ambitious targets.
• Effective oral / written communication skills in German (C1) and English (min B2).
• Residence within approximately 30 minutes commuting distance from Schachen (LU) or willingness to relocate.
• Driver’s license (B) and access to a personal car to enable on-call duties.
• Prior experience in the manufacturing of biologics under GMP, ideally including experience operating a bioreactor.
• Familiarity with the use of automated systems in manufacturing (DeltaV) and electronic batch records (PAS-X).