Scientist (m/f/x) Formulation Technology - Analytics of Biologics

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Scientist (m/f/x) Formulation Technology - Analytics of Biologics

Date: 5 Mar 2025

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:

Scientist (m/f/x) Formulation Technology – Analytics of Biologics

Purpose of the function:

The "Scientist (m/f/x) Formulation Technology", with a focus point: Analytics of Biologics, will be responsible for the planning, organization and hands-on technical support of analytical activities in our Formulation Technology Research Laboratory group for ADC Process Development. In the context of drug product development, the scope of this position will be the establishment of various analytical methods for measuring and assessment of the quality attributes and physicochemical characterization of Biologicals, with focus on parenteral oncology formulations, e.g. ADCs. The position involves both scientific and hands-on support of the operational team members.

Key responsibilities:

Internal transfer and establishment of analytical methods for biologics, including ADCs

Planning, coordination, statistical evaluation and reporting of analytical results related to ADC process development and upscaling activities, incl. stability studies in a GLP environment

Assessment of various quality attributes of ADC process development and process characterization samples using analytical methods (e.g. CE, HPLC, ELISA)

Operation of standard software such as MS Office and evaluation of analytical data using device-specific software (e.g. Empower )

Co-ordinating the maintenance and qualification work of analytical equipment

Scouting, evaluation and onboarding of new analytical technologies for ADC drug products

Co-working with a young development team for expanding the group analytical capabilities with focus on physicochemical characterization and analytical quality assessment of Biologics, as well as laboratory automation and the occupational health and safety concepts for handling of high potent compounds

Contribute to late-stage drug product development laboratory activities

Creation of risk analyses within the framework of formulation and process development of biologics

Supporting the team in creating and reviewing of manufacturing protocols and reports

Collaboration with various international multidisciplinary project teams (incl. colleagues from Japan, US and Europe)

Personal skills and professional experience:

• University degree (in Biochemistry, Chemistry, Pharmacy, Molecular Biology or related disciplines), ideally with a master’s degree or with equivalent work experience within pharmaceutical/biotechnological companies (focus on analytical of Biologics)
• In-depth knowledge and hands-on expertise in analysis of parenteral Biologics; incl. HPLC, Capillary electrophoresis and ELISA. Preferably, with at least two years’ experience within a professional lab
• Experience with Empower, Karat, or OpenLabs is a plus
• Reliable, independent, with sense of responsibility and precise working style
• Hands-on mentality and, above all, enjoyment of working in a team
• Basic knowledge of the regulatory and ICH guidelines
• Intercultural competence and collaborative working skills
• Very good written and oral communication skills in English and German

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.