Associate Specialist Process Operations (M/F/D)
This is an Associate Specialist position within the Process Operations group with a focus on upstream operations. This position requires full-time physical presence at the site to support manufacturing and to enable optimal integration into an existing team. 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:
Set up, practical execution and troubleshooting of upstream and support unit operations in continuous manufacturing and fed-batch processes under Good Manufacturing Practices (GMP)
Knowledge of and compliance to GMP principles and EHS standards in the area of responsibility
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.
Qualification:
Educational background in a relevant discipline
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.
Business Fluent in English and German:
Effective oral / written communication skills in German (C1)
Oral / written communication skills in English (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
Preferred Experience and Skills:
A bachelor’s or master’s degree in a relevant discipline
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)
Requirements:
Start: 01.10.2025
Duration: 12 months
Capacity: 5 days per week
Location: Werthenstein, Switzerland