For one of our client, an international pharmaceutical company, we are seeking an
Associate Specialist Process Operations (Upstream Operations).
General Information:
* Start date:
* End Date:
* Workplace:
Schachen, Luzern
* Home office:
100% onsite
* Workload:
100%
* Working hours:
Standard
This is an
Associate Specialist
position within the
Process Operations
group at our client site in the greater Lucerne area, 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 & 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).