This is an Associate Specialist position within the Manufacturing Operations group at our company in the greater Lucerne area. 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 at MSD Werthenstein BioPharma, you will be responsible for supporting various activities related to the implementation and GMP manufacturing of early-phase clinical therapies.
Responsibilities would primarily entail, but are not limited to, the following:
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)
Knowledge of and compliance to GMP principles and EHS standards in the area of responsibility
Management and documentation of process execution, deviations, changes and CAPAs. Partnering with Quality Assurance and other internal stakeholders during investigations and technical discussions
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
Participation in sampling activities or on-call duties, which may include weekend work
To be successful in this role, you will have the following:
Educational background in a relevant discipline
A minimum of 0-2 years of work experience in the pharmaceutical or biotech industry
Experience (0-2 years) or educational background in upstream or downstream processing. General knowledge of unit operations in manufacturing processes for biologics and of GMP requirements
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.
Business Fluent in English and German
Effective oral / written communication skills in English (C1)
Oral / written communication skills in German (B2)
Preferred Experience and Skills:
A bachelor’s or master’s degree in a relevant discipline
1-2 years of experience in a GMP environment
Experience with quality management and compliance systems (Trackwise/SAP QM/VeevaVault)
Familiarity with the use of automated systems in manufacturing (DeltaV) or electronic batch records (MES)
Prior experience with process development or process scale-up is beneficial
Ability to work efficiently as part of a team, as well as willingness to take responsibility for independent projects
Please note this is a temporary position, more information will be provided upon application.
Seniority level Not Applicable
Employment type Other
Job function Manufacturing
Industries Pharmaceutical Manufacturing
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