(Senior) Technician DSP

Batavia Biomanufacturing; Leiden; On-site; EUR 60,000 - 90,000; Full time

Job summary

A leading biomanufacturing company located in Leiden is seeking a (Senior) DSP Technician to execute complex downstream processing operations in a GMP-compliant environment. You will play a crucial role in establishing and shaping the department, with responsibilities including the purification of cell culture harvests and maintaining compliance with GMP guidelines. Candidates should have extensive experience with DSP techniques and be highly accurate in documentation, with leadership skills being a plus.

Qualifications

• Several years of experience in a GMP manufacturing environment.
• Highly accurate in documentation.
• Experience in drafting and/or reviewing batch documentation.
• Experience with viruses is preferred; leadership or coaching skills are a plus.
• Experience in start-up phase of a new facility or CDMO is a plus.

Responsibilities

• Execute complex DSP operations within a GMP-compliant environment.
• Set up and execute purification of mammalian cell culture harvests.
• Ensure availability of DSP materials and equipment.
• Document production steps and ensure batch records comply with GMP.
• Contribute to process improvements and safety procedures.
• Support knowledge sharing and training within the team.

Skills

Experience in GMP manufacturing

GMP behavioral standards adherence

Accuracy in documentation

Experience with DSP techniques

Ability to perform complex DSP processes

Start-up phase experience

Job description

About the position

As a (Senior) DSP Technician, you will be responsible for independently executing complex Downstream Processing (DSP) operations within a GMP‑compliant environment.

Earlier this year, we moved into our new state‑of‑the‑art facility, and in this initial phase, you will play an important role in further establishing and shaping the department. Once production is fully operational, you will take on a key role in both the hands‑on execution and the documentation of manufacturing processes. In addition, you will actively contribute to knowledge sharing and training within the team.

Area of Responsibilities

• Setting up and executing the purification of clinical and large scale mammalian cell culture harvests as part of the manufacture of recombinant medicinal products including therapeutic proteins, viral vectors and vaccines.
• Performing downstream processing activities with Chromatography skids, TFF systems and other systems, including handling of viruses.
• Ensure availability of DSP materials needed for the execution of the GMP process.
• Ensure equipment availability for the execution of the process.
• Execute the downstream production processes up to storage of products/intermediates, according to production batch records.
• Perform activities according to GMP guidelines.
• In case needed, participate in the execution of engineering run and R&D processes to facilitate the technology transfer from R&D into production facility.
• Participate to maintain safety procedures for the production facility.
• Contributing to problem solving efforts and root cause investigations to resolve deviations related to equipment, processes or products.
• Demonstrating a strong focus on continuous improvement & efficiency, identifying and completing improvement projects.
• Perform daily, weekly and periodic cleaning of surfaces and equipment.
• Demonstrate a safety first mindset with a focus on adherence to EHS procedures.

Required skillset/experience

• Several years of experience in a GMP manufacturing environment.
• Familiar with adhering to GMP behavioral standards.
• Highly accurate in documentation.
• Extensive experience with DSP techniques.
• Experience in drafting and/or reviewing batch documentation.
• Ability to independently perform complex DSP processes.
• Experience with viruses is preferred.
• Leadership or coaching skills are a plus.
• Experience in the start‑up phase of a new facility or CDMO is a plus.

Seniority level

Associate

Employment type

Full‑time

Job function

• Production
• Pharmaceutical Manufacturing
• Biotechnology Research

Leiden, South Holland, Netherlands