Daiichi Sankyo

Passion for Innovation. Compassion for Patients.

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/d) USP

Purpose of the function

As a Bioprocess Specialist USP you will be responsible for the upstream 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.

Roles & Responsibilities

• You will perform upstream processing steps in our Test&Trainingscenter (working cell bank generation, cell culture expansion, fermentation (fed-batch and perfusion), harvesting)
• 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 upstream area as well as for the optimization of production flows.
• You will be involved in regular reporting to and communication with Japanese collaboration team.

Professional experience & Education

• University degree in biotechnology or comparable
• Sound knowledge and several years of experience in the cultivation and fermentation of CHO cells as well as the handling of single-use systems (ideally in a biopharmaceutical company)
• Experience with production scales of 500 L fed-batch 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

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

For more information: www.daiichi-sankyo.eu