Bioprocess Specialist (m/f/x) PCS-lab

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.

For our site in Pfaffenhofen/Ilm we are seeking highly qualified candidates to fill the position:

Bioprocess Specialist (m/f/x) PCS-lab

Purpose of the function:

As a Bioprocess Specialist PCS-lab with focus on USP processes you will be mainly responsible for the establishment of a laboratory with a focus on upstream processes at small scale and equipment of the new BioDS building and contribute to Daiichi Sankyo’s future ADC portfolio. You will work in a dynamic team on the establishment of a new laboratory and the characterization of new production processes for monoclonal antibodies. 

Roles & Responsibilities:

• You will be involved in the correct procurement, installation, qualification and validation of bioprocess equipment for the PCS-laboratory according to GMP-like 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 laboratory according to GMP-like standards and contribute to its maintenance (e.g. writing and review/approval of SOPs and process equipment recipes, general laboratory concepts; Management and procurement of long-lead manufacturing consumables)
• You will contribute to the preparation and review of documentation for example for dossiers
• You will be responsible for the training of future operators in the laboratory 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
• 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
• Experience in DoE and small-scale benchtop fermenters for mammalian cell culture
• Experience in Process Transfer from small to large-scale and/or vice-versa
• GMP or GLP 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