Associate Specialist Downstream Operations

Randstad Switzerland; Luzern; Vor Ort; CHF 70.000 - 110.000; Vollzeit

Zusammenfassung

Randstad Switzerland is recruiting for an Associate Specialist within the Downstream Operations group for an international pharmaceutical company based in Lucerne. You will support GMP manufacturing activities for early-phase therapies in a 1-year assignment with on-site work and occasional on-call duties.

The role requires a biology-related education and 1–2 years of pharma/biotech experience, with fluency in English and German, and willingness to relocate near Schachen.

Qualifikationen

• 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.
• 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.

Aufgaben

• Set up, practical execution and troubleshooting of downstream processes under GMP.
• Knowledge of and compliance to GMP principles and EHS standards in the area of responsibility.
• Involvement in continuous improvement efforts and support for new technologies, including non-GMP engineering runs or testing activities.
• Creation and updates of SOPs and (electronic) master batch records. Technical review of process transfer and GMP documentation.
• Participation in sampling activities (including occasional weekend work) or on-call duties; typical manufacturing activities do not include shift work.

Kenntnisse

GMP knowledge

Problem solving

English & German fluent

Stakeholder collaboration

Ausbildung

Biotechnology

Tools

DeltaV

PAS-X

Jobbeschreibung

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:

• Duration: 1 year
• Extension: possible (to be discussed)
• Contract type: temporary contract via Randstad (employment)
• Home office: not possible, 100% onsite
• 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.
• 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)