Job Description
A Manufacturing Operations Specialist is required by our client, an international pharmaceutical company.
Key Information:
* Duration: April 1, 2025 - March 31, 2026
* Workplace: Schachen, Lucerne
* Workload: Full-time (100%)
* Remote Work: Not available
This specialist position will be part of the growing manufacturing team in the greater Lucerne area. The role requires full-time presence at the site to support manufacturing activities related to the implementation and GMP manufacturing of early-phase clinical therapies.
Responsibilities:
* Process Execution: Set up, practical execution, and troubleshooting of upstream, downstream, and support unit operations in continuous manufacturing and fed-batch processes under Good Manufacturing Practices (GMP).
* Documentation and Management: Manage and document process execution, deviations, changes, and CAPAs. Partner with Quality Assurance and other internal stakeholders during investigations and technical discussions.
* Continuous Improvement: Involve in continuous improvement efforts and support for the implementation of new technologies, including non-GMP engineering runs or testing activities.
* Document Creation: Create and update SOPs and (electronic) master batch records. Conduct technical review of various documentation related to process transfer and GMP manufacturing.
* Material Management: Utilize ERP systems (SAP) for material management.
* Mentoring and Training: Mentor and train junior team members, actively participate in knowledge transfer.
* Sampling Activities: Participate in sampling activities or on-call duties, which may include weekend work.
Requirements:
* Educational Background: Relevant educational background.
* Industry Experience: Minimum 2-5 years of work experience in the pharmaceutical or biotech industry.
* GMP Experience: Minimum 2 years of practical experience in the manufacturing of biologics under GMP, either in upstream or downstream processing or support operations.
* Technical Knowledge: Expert knowledge of some unit operations in upstream or downstream processing of biologics. Prior experience with continuous manufacturing is desirable but not required.
* Critical Thinking: Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve, and develop.
* Communication Skills: Effective oral/written communication skills in English (C1). Oral/written communication skills in German (B1-B2).
Priorities:
* Education: Bachelor's or Master's degree in a relevant discipline.
* Quality Management: Experience with quality management and compliance systems (Trackwise/SAP QM/VeevaVault).
* Automated Systems: Familiarity with the use of automated systems in manufacturing (DeltaV) or electronic batch records (MES).
* Process Development: Prior experience with process development or process scale-up is beneficial.
* Teamwork: Ability to work efficiently as part of a team, as well as willingness to take responsibility for independent projects.