Laboratory Technical Specialist

Laboratory Technical Specialist (m/f/d) – Pharma / GMP / German / English / large data volumes

Background:

At the Basel Drug Substance site, we produce three technologies in two manufacturing units – Monoclonal Antibody (MAB) in MU B95, Antibody Drug Conjugates (ADCs), and Single Use Technology (SUT) in MU B91 – high-quality pharmaceutical active ingredients to supply patients worldwide with medicines. The Manufacturing Lab team offers you the opportunity to independently take on varied and challenging tasks in a biological production environment. Become part of our team and actively contribute to the development and manufacture of innovative medicines by participating in the following processes: As a support unit, you will support the WCB (= Working Cell Bank) thawing process. You will accompany and advise interfaces on the correct system-technical implementation of the E2E process (= end-to-end processes) for process samples and their analyses in the production buildings. You will process deviations related to the sample management process and work on new and existing risk analyses. You will implement continuous improvement processes as part of CAPA measures and participate in inspection management. You will be part of the first-level support for your own team and interfaces regarding questions related to the sample management process.

The ideal candidate: has completed vocational training or a university degree in a scientific or technical field, preferably in biotechnology, and at least five years of experience in a pharmaceutical environment under GMP conditions. They work analytically, independently, and flexibly, are fluent in German and have a good command of English. Thanks to their strong IT affinity, they quickly understand complex systems, reliably analyze large amounts of data, and efficiently implement new requirements in practice.

Main tasks and areas of responsibility:

• Independent development and optimization of process workflows with a focus on laboratory activities in biotechnological drug production (e.g. switching on and starting up laboratory equipment, measuring samples as well as equipment maintenance, servicing or calibration)
• Support in the development and optimization of process flows (see background text above) in the GMP environment
• Independent processing of deviations and CAPA within the quality management system
• Change Management: Creation and processing of process changes
• Processing, reviewing and approving documents (= laboratory documents such as sample management SOPs, device SOPs, thawing SOPs)
• Documentation (in the Veeva system)

Must Haves:

• A completed apprenticeship or a bachelor's degree (desirable) in a scientific or technical field, preferably in biotechnology.
• At least 5 years of professional experience and knowledge in the pharmaceutical field and working under GMP * Fluent in German and good knowledge of English
• Ability to adapt to a rapidly changing environment with changing priorities and respond flexibly to requests
• Experience and interest in analyzing large amounts of data and strengths in working independently and responsibly
• Very experienced in dealing with IT systems and the ability to quickly understand complex systems and relationships and implement them in practice

Nice to haves:

• Experience in project coordination and project management
• Laboratory software applications (LIMS and Unilab) and, if necessary, MES

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Reference No.: 924522SBI

Role: Laboratory Technical Specialist (m/f/d)

Industry: Pharmaceuticals

Location: Basel

Workload: 100%

Earliest start:

Latest start:

Duration: 9 months++

Application deadline :

Job Type: 100%

Work Location: On the road