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Associate Specialist – Downstream Operations (12‑month contract)
CK QLS · Lucerne
Description du poste
About the role
We are looking for an Associate Specialist to join our Downstream Operations team in the greater Lucerne area for a 12‑month fixed‑term contract. The role is based on‑site and supports GMP manufacturing of early‑phase clinical therapies, working closely with the existing manufacturing team.
Key responsibilities
- Set up, execute and troubleshoot downstream processes under GMP conditions.
- Maintain compliance with GMP and EHS standards.
- Participate in continuous‑improvement projects and pilot new technologies, including non‑GMP engineering runs.
- Draft and update SOPs and electronic master batch records; perform technical reviews of process transfer documentation.
- Manage materials using SAP and support sampling activities, including occasional weekend or on‑call duties.
Required profile
- 1–2 years of experience in pharmaceutical or biotech manufacturing.
- Strong problem‑solving mindset and ability to work under pressure in a GMP environment.
- Fluent in German (C1) and English (B2+), both written and spoken.
- Residence within 30 minutes of Schachen (LU) or willingness to relocate; valid driver’s licence and personal car.
Required skills
- Downstream bioprocess techniques: capture/polishing chromatography, virus filtration, UF/DF, formulation, fill‑and‑freeze.
- Experience with automated control systems (DeltaV) and electronic batch record systems (PAS‑X).
- Material management using SAP.
What we offer
- Full‑time on‑site position within a dynamic, multidisciplinary team.
- Opportunity to work on cutting‑edge clinical therapy manufacturing.
- Professional development in a regulated GMP environment.
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CK QLS
Lucerne
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