Bioprocess Specialist (m/f/x) DSP

JR Germany; Pfaffenhofen an der Ilm; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

Une entreprise biopharmaceutique de premier plan, avec plus de 120 ans d'expérience, recherche un Bioprocess Specialist pour son nouveau bâtiment BioDS. Le candidat sera chargé des processus en aval, de l'optimisation des méthodes de production, et de la formation des futurs opérateurs. Rejoignez une équipe dynamique pour contribuer à des projets innovants dans le domaine des anticorps monoclonaux.

Qualifikationen

• Expérience en traitement en aval des biothérapeutiques, idéalement dans un environnement de production biopharmaceutique.
• Connaissance des techniques de purification et des compétences en qualification / validation selon GMP.
• Bilingue en allemand et en anglais, avec d'excellentes compétences en communication.

Aufgaben

• Responsable des processus en aval et de l'établissement de l'environnement GMP.
• Formation des opérateurs pour la production et optimisation des flux de production.
• Collaboration avec diverses équipes et rédaction de documents de qualification.

Kenntnisse

Chromatographie

Filtration

Inactivation virale

Comprehension rapide

Autonomie

Ausbildung

Diplôme universitaire en biotechnologie ou équivalent

Tools

Microsoft Office

Jobbeschreibung

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Job Views:

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Posted:

14.06.2025

Expiry Date:

29.07.2025

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Job Description:

With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.

In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.

We are seeking a highly qualified candidate to fill the position:

Bioprocess Specialist (m/f/x) DSP

Purpose of the function:

As a Bioprocess Specialist DSP you will be responsible for the downstream processes and equipment of the new BioDS building and contribute to Daiichi Sankyos future ADC portfolio. You will work in a young, dynamic team on the implementation of new production processes for monoclonal antibodies and their analysis in our newly established process development laboratory (Test&Training Center). You will support the process transfer from the Test&Training Center to the GMP production from Daiichi Sankyo in our new BioDS building, which is currently in construction.

• You will perform downstream processing steps in our Test&Trainingscenter (preparative chromatography, virus inactivation, ultra/diafiltration, final bulk filling)
• You will be involved in the correct procurement, installation, qualification and validation of bioprocess equipment for BioDS according to GMP guidelines
• You will be involved in the collaboration with the project team and different departments (e.g. quality management, engineering, procurement) and with different external companies (e.g. general planning company, sub-companies and vendors)
• You will contribute to establish a regulated manufacturing GMP environment and contribute to its maintenance (e.g. writing and review/approval of SOPs, Master Batch Records and process equipment recipes, hygienic concept; Management and procurement of long-lead manufacturing consumables)
• You will contribute to the preparation and review of qualification and validation documentation as well as the processing of deviations and changes
• You will be responsible for the training of future operators for the GMP production including the implementation of a training concept.
• You will be responsible for the independent establishment and optimization of biotechnological process steps in the downstream area as well as for the optimization of production flows.
• You will be involved in regular reporting to and communication with Japanese collaboration team.
• University degree in biotechnology or comparable
• Sound knowledge and several years of experience in the downstream processing of biotherapeutics, with a focus on chromatography, TFF, and filtration) (ideally in a biopharmaceutical production environment)
• Experience with production scales of 500 L or higher
• GMP experience is an advantage

Personal skills

• You have a fast comprehension
• You are self-reliant and show initiative
• You work carefully with a high degree of reliability and sense of responsibility
• Hands-on mentality
• Required language skills: German and English (very good spoken and written skills)
• IT skills: Microsoft Office applications