Associate Scientist

nemensis ag Schweiz; Luzern; Vor Ort; CHF 80.000 - 100.000; Vollzeit

Zusammenfassung

nemensis ag Schweiz is seeking an Associate Specialist Downstream Operations (m/f/d) in the Lucerne area. The role focuses on hands-on downstream bioprocessing, including chromatography, virus filtration, UFDF, and formulation under GMP.

A Bachelor’s or Master’s degree and 1–2 years’ biotech experience are preferred. Responsibilities include SOP authoring, batch record reviews, SAP materials management, and supporting technology integrations.

Qualifikationen

• Degree (Bachelor's or Master's) in Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related discipline.
• Minimum 1–2 years of professional experience in the pharmaceutical or biotech industry, ideally GMP biologics manufacturing.
• Familiarity with downstream unit operations (chromatography, virus filtration, UFDF, formulation).
• Knowledge of automated manufacturing systems (DeltaV) and electronic batch record systems (PAS-X) is advantageous.

Aufgaben

• Execute and troubleshoot downstream manufacturing processes in GMP compliance (chromatography, virus filtration, UFDF, formulation, fill & freeze).
• Author and revise SOPs and electronic batch records; conduct technical reviews of process transfer and GMP documentation.
• Manage materials and inventory using ERP systems (SAP) to ensure smooth production scheduling.
• Support integration of new technologies and non-GMP engineering runs within continuous improvement initiatives.
• Participate in sampling activities, including occasional weekend or on-call duties as required by process scheduling.
• Ensure adherence to EHS regulations and GMP principles within area of responsibility.

Kenntnisse

Downstream unit operations

Chromatography

Virus filtration

UFDF

Formulation

DeltaV

PAS-X

Problem solving

German (C1)

English (B2+)

Ausbildung

Bachelor's or Master's degree in Biotechnology/Biochemistry/Pharmaceutical Sciences

Tools

SAP

DeltaV

PAS-X

Jobbeschreibung

Associate Specialist Downstream Operations (m/f/d)

Where Science Meets Purpose Join a Team Shaping Tomorrow's Therapies

• Duration: 12 months (temporary assignment)

About Our Client

Our client is an internationally active, innovation-driven biotech company based in the greater Lucerne area, operating at the forefront of early-phase clinical biologics manufacturing. With state-of-the-art GMP facilities and a strong commitment to scientific excellence, this organisation plays a key role in bringing life-changing therapies from the lab to the clinic.

Your Responsibilities as Associate Specialist Downstream Operations (m/f/d)

• Execute and troubleshoot downstream manufacturing processes (e.g. chromatography, virus filtration, UFDF, formulation, fill & freeze) in full compliance with GMP standards
• Author and revise SOPs and electronic master batch records; conduct technical reviews of process transfer and GMP manufacturing documentation
• Manage materials and inventory using ERP systems (SAP) to ensure smooth production scheduling
• Support the integration of new technologies, including non-GMP engineering runs and testing activities within continuous improvement initiatives
• Participate in sampling activities, including occasional weekend or on-call duties as required by process scheduling
• Ensure adherence to EHS regulations and GMP principles within your area of responsibility

Your Profile

• Degree (Bachelor's or Master's) in Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related discipline
• Minimum 1–2 years of professional experience in the pharmaceutical or biotech industry, ideally in GMP biologics manufacturing
• Practical knowledge of downstream unit operations such as chromatography (capturing & polishing), virus filtration, UFDF, and formulation
• Familiarity with automated manufacturing systems (e.g. DeltaV) and electronic batch record systems (e.g. PAS-X) is a strong advantage
• Strong problem-solving mindset with the ability to work under pressure in a complex GMP environment
• Business fluent in German (C1) and proficient in English (B2+); both written and spoken
• Residing within approximately 30 minutes of Schachen (LU) or willingness to relocate; valid driver's licence (category B) required