For one of our clients, an international pharmaceutical company based in canton Lucerne, we are seeking an Associate Specialist within the Downstream Operations group.
As a member of the manufacturing team at our client's company, you will be responsible for supporting various activities related to the implementation and GMP manufacturing of early-phase clinical therapies.
General Information:
- Start date: ASAP
- Duration: 1 year
- Extension: possible (to be discussed)
- Contract type: temporary contract via Randstad (employment)
- Workplace: Schachen, Lucerne
- Home office: not possible, 100% onsite
- Workload: 100%
- Working hours: Standard with on-call duties
Tasks & Responsibilities: ...
- Set up, practical execution and troubleshooting of downstream 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.
Your Profile:
- Educational background in a relevant discipline (e.g. Biotechnology)
- A minimum of 1-2 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
- 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
Nice to have:
- Prior experience in the manufacturing of biologics under GMP, ideally including experience operating capturing and polishing chromatography, virus filtration, UFDF, formulation, fill & freeze
- Familiarity with the use of automated systems in manufacturing (DeltaV) and electronic batch records (PAS-X)
Sounds interesting? Apply now – we’re looking forward to receiving your applications!